Research articles by Palani Shanmugasundaram
Space Pharmacology is the study of use of pharmaceutical drugs during spaceflights Space flight
c... more Space Pharmacology is the study of use of pharmaceutical drugs during spaceflights Space flight
can alter administered drug act on the body. Pharmacology scientists are conducting research to
improve crew health and well-being. Astronauts are not the only ones who benefit from space
medicine research. Space pharmacology research will benefit health care on Earth. Several
medical products have been developed that are space spinoffs, that is practical applications for
the field of medicine arising out of the space program. It is difficult to conclude the optimal drug
regimens in microgravity to ensure safe, effective, and definitive treatment of space travellers.
This study is mainly focused on the health issues in space, space medicine for astronauts,
pharmacokinetic, pharmacodynamics and pharmacotherapeutics in space and medicine spinoffs.
Keywords: Microgravity, space suits, spinoffs
There is a lack of reliable hepatoprotective drugs in modern medicine to prevent
and treat drug-i... more There is a lack of reliable hepatoprotective drugs in modern medicine to prevent
and treat drug-induced liver damage. Chonemorpha fragrans belonging to family
Apocynaceae are used traditionally for their hepatoprotective effect. We wanted to evaluate
the hepatoprotective activity of Chonemorpha fragrans and observe whether synergistic
hepato-protection exists with silymarin. The in vitro antioxidant and in vivo hepatoprotective
effects of alcoholic extract of Chonemorpha fragrans (C. fragrans) root were evaluated in
rats against paracetamol and Isoniazid models. The antioxidant activity of C. fragrans was
assayed and activities were compared to standard antioxidant, ascorbic acid. The results
revealed that the IC50 values of C. fragrans root extract for DPPH, hydroxyl, superoxide
radical scavenging activities were 198.7±0.2, 275.7 ± 0.8 and 177.4±0.4 μg/mL, respectively.
Liver injury was induced by paracetamol (2gm/kg) Isoniazid (100 mg/kg) orally for 14 days.
The two different set of experiments the Chonemorpha fragrans extracts (200 and 400
mg/kg) and silymarin (25 mg/kg) were administrated orally in preventive models. The
Chonemorpha fragrans and silymarin administration prevented the toxic effect of
Paracetamol and Isoniazid the biochemical parameters in preventive model. The present
study concludes that ethanolic extract of Chonemorpha fragrans root has significant
antioxidant and hepatoprotective activity against induced Paracetamol and Isoniazid
hepatotoxicity.
Journal of Applied Pharmaceutical Science 01/2015; DOI: 10.7324/JAPS.2015.50404, Apr 1, 2015
ABSTRACT: Objective: The development of new delivery systems for the controlled release of drugs ... more ABSTRACT: Objective: The development of new delivery systems for the controlled release of drugs is one of the most innovative fields of research in pharmaceutical sciences. Nanoparticles specially designed to release the drug in the vicinity of target sites. The aim of this study was to formulate and evaluate the Lansoprazole nanoparticles to improve the therapeutic efficacy of Lansoprazole by loading in nanoparticle drug delivery system. Materials and Methods: Lansoprazole loaded chitosan nanoparticles (CNP1 to CNP10) were prepared by ionotropic gelation method. The formulated nanoparticles were evaluated for external morphological characters, determination of particle size analysis, zeta potential, drug content, entrapment efficiency and in-vitro release studies. Results: The drug content for the Lansoprazole loaded chitosan nanoparticles varied from 69.5±7.2% to 87.9±1.2%. The entrapment efficiencies were found to be minimum and maximum of 39.3±2.6% and 85.6±1.2%, the optimum entrapment efficiency was found to be 85.3±0.8%, particle size varied from 360±12nm to 814±62nm, zeta potential values were in positive and increased from 11.2±1.2mV to 18.7±0.4mV. In-vitro release of drug follows zero order and showed sustained release behavior for a period of 24 hr. Conclusion: The study demonstrated the successful preparation of sustained release polymeric nanoparticles of Lansoprazole.
International Journal of Pharma and Bio Sciences ISSN0975-6299, Jul 2014
A co-processed excipient was prepared from Tamarind seed polysaccharide (TSP) and
mannitol in us... more A co-processed excipient was prepared from Tamarind seed polysaccharide (TSP) and
mannitol in using direct compression as well as wet and dry granulation. The effect of the
ratio of the two components, percentage of lubricant and particle size on the properties of
the prepared co-processed excipient has been investigated. Optimal physicochemical
properties of the excipient, from a manufacturing perspective, were obtained using a coprocessed
mannitol- TSP (2:8 w/w) mixture prepared by wet granulation. Disintegration
time, crushing strength and friability of tablets produced by co-processed mannitol- TSP,
using magnesium stearate as a lubricant, were found to be independent of the particle
size of the prepared granules. The inherent binding and disintegration properties of the
compressed co-processed mannitol- TSP are useful for the formulation of poorly
compressible, low and high strength active pharmaceutical ingredients. The ability to coprocess
Tamarind seed polysaccharide (TSP) with crystalline mannitol allows TSP to be
used as a valuable industrial pharmaceutical excipient. The aim of present study was to
formulate and evaluate an oral sustained release tablet of Propranolol hydrochloride to
increase therapeutic effect, reduced frequency of administration and improved patient
compliance. Propranolol HCl tablet was formulated by using co-processed excipients
Tamarind seed polysaccharide and mannitol. Formulations were prepared by varying the
polymer concentration. The optimized formulations were subject to stability testing as per
ICH guidelines.
KEYWORDS- Propranolol HCl, Tamarind seed polysaccharide (TSP), co-processed excipients
Indo American Journal of Pharm Research.2014:4(07)., Jul 2014
Process Analytical Technology (PAT) has been introduced as an advent of new tool which has given ... more Process Analytical Technology (PAT) has been introduced as an advent of new tool which has given an opportunity for all the pharmaceutical manufacturers to improve upon their quality and compliance. The application of this technology in pharmaceutical manufacturing ensures the quality of raw material attributes that too at-line, in-line or on-line, which was difficult earlier, thereby decreasing the chances of error and significant savings in time required for testing.. In this article, Process Analytical Technology has been introduced briefly and explained its different tool in order to illustrate how application of this technology ensures quality of pharmaceutical products by implementing Online measurement in existing pharmaceutical utility system (eg.Online TOC analyzer) and through this implementation, significant amount of process loss has been minimized and it also enhances delivering quality products at right time first time. In Total, Process Analytical Technology lays a way for producing a standard product which is in line with Quality and thus creating a satisfaction with customer needs and making a good brand image for the organization.
International Journal of Pharma and Bio Sciences ISSN 0975-6299, Jan 2014
The curtius rearrangement of Ethyl - 1 - (2 – azido – 2 - oxoethyl) – 6 – methyl – 2 – oxo – 4 – ... more The curtius rearrangement of Ethyl - 1 - (2 – azido – 2 - oxoethyl) – 6 – methyl – 2 – oxo – 4 – (3 – substituted) - 1, 2, 3, 4 – tetrahydropyrimidine -5 – carboxylate prepared from the
readily accessible 4 - (1 – substituted) – 5 - ethoxy carbonyl – 6 - methyl] - 3, 4 –dihydropyrimidine – 2 (1H) – one was investigated in presence of ethanol, substituted phenols and substituted amines. ........
International journal of PharmTech Research, Aug 2014
Abstract: A High performance liquid chromatographic method has been developed and optimized for a... more Abstract: A High performance liquid chromatographic method has been developed and optimized for antiretroviral drugs (Abacavir and Lamivudine). Multiple response simultaneous optimization using the Derringer’s desirability function was employed for the development of RP-HPLC. The possibilities of the simultaneous drug analysis allow a decrease of time during the assay and save reagents and solvents. The ranges of independent variables used for the optimization were MeOH (65-75%v/v), pH (6.0 -7.0), flow rate (0.8 -1.2 ml/min). The influence of these variables on the output responses such as capacity factors of the first peak (k1), resolutions (Rs1,2) and retention time (tR2)were evaluated. The experimental responses were fitted into a second order poly nominal and the three responses were simultaneously optimized to predict the optimum conditions for the effective separation of the studied components. Optimum conditions chosen for assay were MeoH: phosphate buffer (74.3:25.7%v/v) (pH 6.85, buffer strength 0.05M) and flow rate of 1.2 ml/min.The eluate was monitored using an UV detector set at 260 nm. Total chromatographic analysis time was approximately 5.0 min. The optimized assay condition was validated as per International Conference on Harmonization guidelines to confirm specificity, linearity, accuracy, limit of detection, limit of quantification
and precision.
The aim of this work was the chemical modification of pectin by limited acetylation of their free... more The aim of this work was the chemical modification of pectin by limited acetylation of their free hydroxyl groups to yield high ester pectin and to investigate its swelling and erosion behavior along with the effect on the release pattern of drugs. Propranolol as an antihypertensive drug was formulated as tablet using chemically modified pectin and pure pectin by using wet granulation method and its collision on drug release was studied. Physicochemical characterization of chemically modified pectin, the solubility, gelling or swelling factor was studied. Optimum concentrations of the modified pectin in such a system protect the tablet throughout the gastrointestinal tract. The pectin modified with acetylating agent was found to be promising to modify the release of drugs which are to be delivered throughout GIT. Drug dissolution studies were carried out in buffers of pH 1.2 and 6.8 and the system was designed based on the total GIT transit time concept. The matrix tablet of modified pectin show more release retardant action as compared to pure pectin. Modified dosage form subject to sintering technique it show fast disintegration and dissolution.
Journal of Liquid Chromatography & Related Technologies 01/2014; 37(3):298-310. · 0.57 Impact Factor, 2014
ABSTRACT: A fast, selective, and sensitive reversed phase ultra performance liquid chromatographi... more ABSTRACT: A fast, selective, and sensitive reversed phase ultra performance liquid chromatographic (UPLC) method employing C-18 column has been developed and validated for the simultaneous analysis of doripenem (DOR) and its degradation products, Impurity 1[5-(1-Carboxy-2-hydroxypropyl)-4-methyl-3-(5-((sulfamoylamino) methyl)pyrrolidin-3-ylthio)-4,5-di hydro-1H-pyrrole-2-carboxylic acid], and Impurity 2 [2,2′-(2,7-Dimethyl-5,10-dioxo-1,6-bis(5-((sulfamoylamino)methyl)pyrrolidin-3-yl thio)-2,3,5,7,8,10-hexahydropyrrol[1,2-a:1′,2′-d]pyrazine-3,8-diyl)bis(3-hydroxybutan oic acid)]. The best separations were achieved by a gradient elution with mobile phase consisting of a mixture of phosphate buffer 10 mM, pH 6.0, at a flow rate of 1.0 mL per minute. Column temperature was selected as 45°C where the detection was carried out at 210 nm and 300 nm. The method was found to be precise, linear, accurate, and used to quantify the impurities and potency during stability sample analysis of doripenem.
Inventi Rapid: NDDS Vol.2014; Issue 3:1-3. 01/2014; 2014(2):14., 2014
ABSTRACT: The purpose of this study was to compare the lansoprazole efficacy in chitosan nanopart... more ABSTRACT: The purpose of this study was to compare the lansoprazole efficacy in chitosan nanoparticles and PLGA nanoparticles to identify the optimized formulation and to choose a opt carrier. For these ten formulations of chitosan nanoparticles (CNP1 to CNP10) and ten formulations of PLGA (PNP1 to PNP10) were prepared. The optimized formulations of chitosan nanoparticles (CNP5) and PLGA nanoparticles (PNP7) were taken for the comparative study. The results revealed that, nanoparticles prepared with PLGA possessed ideal characters than the nanoparticles prepared with chitosan.
Inventi Rapid: NDDS. 02/2014; 2014(2):1-4., 2014
ABSTRACT: Nanotechnology is a broad field which involves variety of applications including drug d... more ABSTRACT: Nanotechnology is a broad field which involves variety of applications including drug delivery, diagnostics etc. In recent years there has been increasing interest in the drug delivery for reducing the dose and targeting the drug to the site of action. This leads to development of novel systems like nano drug delivery systems. In these systems, nanoparticles hold special features like controlled / targeted drug delivery and reduced side effects. This review article throws light on advantages, method of preparation, characterization and applications of nanoparticles.
International Journal of PharmTech ResearchVol.5, No.4, pp 1736-174, Oct-Dec 2013, Dec 2013
A simple, accurate, specific and reliable RP-HPLC method for the simultaneous estimation of Sitag... more A simple, accurate, specific and reliable RP-HPLC method for the simultaneous estimation of Sitagliptin Phosphate and Metformin Hydrochloride in Pharmaceutical dosage form was developed and validated according to currently accepted ICH guidelines of analytical method validation. In the present method, SHIMADZU HPLC with UV detector LC 10 AT VP with analytical column PHENOMENEX Luna (C18) A 100 RP Column, 250 mm x 4.6 mm x 5μm, an injection volume of 20µl was injected and eluted with mobile phase 0.02M Potassium dihydrogen phosphate pH(4.0) : Acetonitrile (60:40) pumped at a flow rate of 1.0ml/min. Sitagliptin Phosphate and Metformin Hydrochloride were eluted at 2.718 and 1.925 min. The detection was carried out at a wavelength 252nm. The method was validated for system suitability, linearity, accuracy, precision and robustness of sample solution. The linear ranges for Metformin Hydrochloride and Sitagliptin Phosphate were 20-120μg/mL, 2-12μg/mL respectively with good recoveries i.e. 99.4% to 101.35%.
International Journal of ChemTech ResearchVol.5, No.6, pp 289-2912, Oct-Dec 2013, Dec 2013
Literature survey reveals that partially reduced pyridine and pyrimidine derivatives are known to... more Literature survey reveals that partially reduced pyridine and pyrimidine derivatives are known to have antihypertensive property. Most of the clinically used calcium channel blockers like nifedipine, amlodipine have 1, 4-dihydropyridine ring system containing methylcarboxylate side chain at 3rd position. In the present investigation calcium channel blocker effect of containing carbamate and carbamide side chain has been studied. The key starting material diethyl -4-methyl -2-oxo -6-phenyl -3,6-dihydropyrimidine -1,5-dicarboxylate (2) was synthesized as per literature and ethyl carboxylate side chain present at 1st position was exploited without affecting the same chain at 5 th position. Compound (2) was treated with hydrazine hydrate to form ethyl-1-[(hydrazinooxy) carbonyl] -6-methyl -2-oxo -4-phenyl -1, 2, 3, 4-tetrahydropyrimidine -5-carboxylate (3). Transformation of compound (3) to ethyl -3-(azidocarbonyl) -6-methyl -2-oxo -4-phenyl -1, 2, 3, 4-tetrahydropyrimidine carboxylate (4) on treating with sodium nitrite in dioxane and acetic acid was indicated in IR spectra at 2361 cm -1 . Compound (4) was subjected to Curtius rearrangement on treating with ethyl alcohol / appropriate phenol / appropriate amine to yield the title compounds. Success of the reaction was readily seen in the IR spectra by the absence of peak at 2361cm -1 .
International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.5, No.3, pp 179-185, July-Sept 2013, Sep 2013
A new, simple, accurate and sensitive U.V-Spectrophotometric absorbance correction method has
be... more A new, simple, accurate and sensitive U.V-Spectrophotometric absorbance correction method has
been developed and validated for simultaneous estimation of Tenofovir disoproxil fumerate (TDF) &
Emtricitabine (EMT) in a combined tablet dosage form. 50% v/v Methanol was used as solvent. The
wavelengths selected for the absorption correction method were 260 nm & 290 nm. The method was found to be
linear between the range of 5-25 μg/ml for TDF and7-35 μg/ml for EMT. The mean percentage recovery was
found in the range of 99.24%-100.42% and 100.03-101.04% for TDF and EMT respectively at three different
levels of standard additions. The precision (intra-day, inter-day) of method were found within limits (RSD
<2%). Thus the proposed method was simple, precise, economic, rapid and accurate and can be successfully
applied for simultaneous determination of TDF and EMT in combined tablet dosage form.
Keywords : Absorbance correction method, Tenofovir disoproxil fumerate, Emtricitabine.
64th Indian Pharmaceutical Congress THEME – Pharma Vision 2020: Pharmacy Education, Innovation, Strategies & Globalisation 7-9 December 2012, Chennai; 12/2012, 2012
ABSTRACT: Scientific Abstracts Pharmaceutical Analysis and Quality Assurance F-55 64th Indian Pha... more ABSTRACT: Scientific Abstracts Pharmaceutical Analysis and Quality Assurance F-55 64th Indian Pharmaceutical Congress THEME – Pharma Vision 2020: Pharmacy Education, Innovation, Strategies & Globalisation 7-9 December 2012, Chennai Development and validation for simultaneous estimation of pantoprazole and domperidone in pharmaceutical dosage form using RP-HPLC method. Viswanath.V.,Shanmugasundaram.P, Ravichandiran.V School of Pharmaceutical Sciences Vels Institute of Sciences, Technology and Advanced Studies, Chennai -600117, India. The present work deals with the development of a precise, accurate, simple, specific, reliable and less time consuming RP-HPLC method for simultaneous estimation of Pantoprazole and Domperidone in combined dosage form. The proposed method was developed by HPLC Acme 9000 using Inertsil ODS 3V C18 (250×4.6×5) column with an injection volume of 10l was injected and eluted with a mobile phase composition of Ammonium Sulphate, Buffer 6.5 : Acetonitrile (60:40), which is pumped at a flow rate of 1.5ml/min and detected by uv detector at 220nm. The peaks of Pantoprazole and Domperidone are found well separated at 5.093 and 2.476 minutes respectively. The method was validated in accordance with ICH parameters. The calibration was linear in the concentration range of 20-100 μg/ml. The RSD indicates the method is precise and accurate, the mean recoveries were found in the range of 99-101%.The sample recoveries in all formulations were in good agreement with their respective label claims and they suggested non-interference of formulation excipients in the estimation. The retention times of both the drugs is below 6 min thus the method is not time consuming and can be used in laboratories for the routine analysis of combination drugs. Ruggedness of the proposed methods was determined by analysis of aliquots from homogeneous slot by different analysts, using same operational and environmental parameters and the results were within the limits. The method was also specific and robust.
64th Indian Pharmaceutical Congress THEME – Pharma Vision 2020: Pharmacy Education, Innovation, Strategies & Globalisation 7-9 December 2012, Chennai Analytical method development and validation of Trandolapril in tablets by RP-HPLC G.Anusha, P.Shanmugasu; 12/2012, 2012
ABSTRACT: Scientific Abstracts Pharmaceutical Analysis and Quality Assurance F-64 64th Indian Pha... more ABSTRACT: Scientific Abstracts Pharmaceutical Analysis and Quality Assurance F-64 64th Indian Pharmaceutical Congress THEME – Pharma Vision 2020: Pharmacy Education, Innovation, Strategies & Globalisation 7-9 December 2012, Chennai Analytical method development and validation of Trandolapril in tablets by RP-HPLC G.Anusha, P.Shanmugasundaram, A.S.K.Sankar School of Pharmaceutical Sciences Vels Institute of Sciences, Technology and Advanced Studies, Chennai -600117 A High performance liquid chromatography method for quantification of Trandolapril using UV detection was developed and validated using ODS INERTSIL C18 column (250×4.6mm, 5μm) and the mobile phase composition was phosphate buffer and acetonitrile (1: 1) at a flow rate of 1.0ml/min. The monitoring wavelength used was 210nm with UV detection. The method was validated in accordance with ICH parameters. The calibration was linear in the concentration range60% - 140%.The values of RSD are less than 2.0%, indicating the accuracy and precision of the method. The percentage recoveries vary from 99.0 – 101.0%.The retention time for Trandolapril was around 5 min. The method was found to have suitable application in routine laboratory analysis with high degree of accuracy and precision.
journal of pharmacy research 6 (2013) 765 e773, 2013
To develop a stability-indicating reversed phase ultra performance liquid chromatographic
(RP-UP... more To develop a stability-indicating reversed phase ultra performance liquid chromatographic
(RP-UPLC) method for the determination of related substances in Metoclopramide
bulk drugs and pharmaceutical dosage form.
Method: The chromatographic separation was achieved using a Waters X-terra RP18
(150 4.6 mm), 3.5 mm particle size column using the gradient program with mobile phase
consisting of solvent A: 30 mM monobasic sodium phosphate and 2.3 mM of pentane-1-
sulphonic acid sodium salt (pH 3.0 buffer) and solvent-B (Acetonitrile). A flow rate of 1.2 mL/
min and UV detector at 273 nm was used. The runtime was 18 min within which Metoclopramide
and its four impurities, ACETYLMETO, ACMA, CLEE and ACME were well separated.
Results and discussion: Thedrugwas subjectedto stress conditions suchasoxidative, acid&base
hydrolysis, thermal and photolytic degradation. Metoclopramide was found to degrade significantly
in photolytic, oxidative&thermal stress conditions and stable in acid, base, hydrolytic&
humidity stress conditions. The major degradation impurities in oxidation and photolytic
degradation were identified by LCMS. The degradation products were well resolved from the
main peak and its impurities, thus proved the stability-indicating power of the method.
Conclusion: The developed method was validated as per ICH guidelines with respect to
specificity, linearity, limit of detection, limit of quantification, accuracy, precision and
robustness. The calibration curves obtained for the four impurities were linear over the
range 0.062e3.040 mg/mL.
Copyright ª 2013, JPR Solutions; Published by Reed Elsevier India Pvt. Ltd. All rights
reserved.
* Corresponding author. Tel.: þ91 4427141358; fax: þ91 4427156816.
E-mail address: prathyusha.pchgs@gmail.com (P. Sowjanya).
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/jopr
International Journal of Advances in Pharmaceutical Analysis IJAPA Vol. 3 Issue 1 (2013) 01-10 Journal Home Page http://www.ijapa.ssjournals.com Corresponding Author*: prathyusha.pchgs@gmail.com, 2013
Objective: Aim of the present work is to develop a stability indicating ultra performance liquid
... more Objective: Aim of the present work is to develop a stability indicating ultra performance liquid
chromatography (UPLC) method to determine Lidocaine and its degradation impurities in pharmaceutical
dosage forms.
Method: Chromatographic separation was achieved by gradient elution on Agilent eclipse plus C18 (100x4.6)
mm, and 1.8μm column with potassium dihydrogen phosphate buffer (pH 4.50) and acetonitrile within a short
runtime of 14.0 min. The eluted compounds were monitored at wavelength of 230 nm using photodiode array
(PDA) detector, the flow rate was 1.0 mL/min, and the column oven temperature was maintained at 40 ◦C.
Result: The resolution of Lidocaine and six (potential, bi-products and degradation) impurities was greater
than 2.0 for all pairs of components. The repeatability and intermediate precision, expressed by the RSD, were
less than 1.0%. The accuracy and validity of the method were further ascertained by performing recovery
studies. The specificity of the method was investigated under different stress conditions including hydrolytic,
oxidative, photolytic and thermal as recommended by ICH guidelines. Relevant degradation was found to take
place under oxidative condition.
Conclusion: Method was Robustness against small modification in pH, column oven temperature, flow rate
and percentage of the mobile phase composition was ascertained. All these results provide that the method has
stability indicating properties being fit for its intended purpose; it may find application for the routine analysis
of the related substances of Lidocaine formulations.
Keywords: Ultra Performance Liquid chromatography (UPLC); Lidocaine; Validation; Stress Degradation
products
journal of pharmacy research 6 (2013) 214 e217, 2013
Aphthous ulcers (Canker sores) are recurrent multiple ulcers occurring in oral mucosa
mainly in ... more Aphthous ulcers (Canker sores) are recurrent multiple ulcers occurring in oral mucosa
mainly in the buccal mucosa, labial mucosa, floor of the mouth and tongue. The etiology
for aphthous is still not clear though many predisposing factors like stress, trauma,
immunologically mediated, infectious agents like virus etc., are considered. As the etiopathogenesis
of the disease is multifactorial, treatment mainly aims in symptomatic
management of pain or burning sensation using mainly topical anesthetics or antiseptics.
To facilitate the healing process, various anti-inflammatory and anti-allergic agents are
also tried. A medication which could help in reduction of pain, ulcer size, erythema, ulcer
duration and prevent recurrence is essential to treat the ulcers. The efficacy of Amlexanox
in treatment of aphthous ulcers is tried in various clinical trials. This systematic review
article aims in evaluation of Amlexanox efficacy in satisfying all the demands such as
reduction of pain, ulcer size, ulcer duration erythema and recurrence.
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Research articles by Palani Shanmugasundaram
can alter administered drug act on the body. Pharmacology scientists are conducting research to
improve crew health and well-being. Astronauts are not the only ones who benefit from space
medicine research. Space pharmacology research will benefit health care on Earth. Several
medical products have been developed that are space spinoffs, that is practical applications for
the field of medicine arising out of the space program. It is difficult to conclude the optimal drug
regimens in microgravity to ensure safe, effective, and definitive treatment of space travellers.
This study is mainly focused on the health issues in space, space medicine for astronauts,
pharmacokinetic, pharmacodynamics and pharmacotherapeutics in space and medicine spinoffs.
Keywords: Microgravity, space suits, spinoffs
and treat drug-induced liver damage. Chonemorpha fragrans belonging to family
Apocynaceae are used traditionally for their hepatoprotective effect. We wanted to evaluate
the hepatoprotective activity of Chonemorpha fragrans and observe whether synergistic
hepato-protection exists with silymarin. The in vitro antioxidant and in vivo hepatoprotective
effects of alcoholic extract of Chonemorpha fragrans (C. fragrans) root were evaluated in
rats against paracetamol and Isoniazid models. The antioxidant activity of C. fragrans was
assayed and activities were compared to standard antioxidant, ascorbic acid. The results
revealed that the IC50 values of C. fragrans root extract for DPPH, hydroxyl, superoxide
radical scavenging activities were 198.7±0.2, 275.7 ± 0.8 and 177.4±0.4 μg/mL, respectively.
Liver injury was induced by paracetamol (2gm/kg) Isoniazid (100 mg/kg) orally for 14 days.
The two different set of experiments the Chonemorpha fragrans extracts (200 and 400
mg/kg) and silymarin (25 mg/kg) were administrated orally in preventive models. The
Chonemorpha fragrans and silymarin administration prevented the toxic effect of
Paracetamol and Isoniazid the biochemical parameters in preventive model. The present
study concludes that ethanolic extract of Chonemorpha fragrans root has significant
antioxidant and hepatoprotective activity against induced Paracetamol and Isoniazid
hepatotoxicity.
mannitol in using direct compression as well as wet and dry granulation. The effect of the
ratio of the two components, percentage of lubricant and particle size on the properties of
the prepared co-processed excipient has been investigated. Optimal physicochemical
properties of the excipient, from a manufacturing perspective, were obtained using a coprocessed
mannitol- TSP (2:8 w/w) mixture prepared by wet granulation. Disintegration
time, crushing strength and friability of tablets produced by co-processed mannitol- TSP,
using magnesium stearate as a lubricant, were found to be independent of the particle
size of the prepared granules. The inherent binding and disintegration properties of the
compressed co-processed mannitol- TSP are useful for the formulation of poorly
compressible, low and high strength active pharmaceutical ingredients. The ability to coprocess
Tamarind seed polysaccharide (TSP) with crystalline mannitol allows TSP to be
used as a valuable industrial pharmaceutical excipient. The aim of present study was to
formulate and evaluate an oral sustained release tablet of Propranolol hydrochloride to
increase therapeutic effect, reduced frequency of administration and improved patient
compliance. Propranolol HCl tablet was formulated by using co-processed excipients
Tamarind seed polysaccharide and mannitol. Formulations were prepared by varying the
polymer concentration. The optimized formulations were subject to stability testing as per
ICH guidelines.
KEYWORDS- Propranolol HCl, Tamarind seed polysaccharide (TSP), co-processed excipients
readily accessible 4 - (1 – substituted) – 5 - ethoxy carbonyl – 6 - methyl] - 3, 4 –dihydropyrimidine – 2 (1H) – one was investigated in presence of ethanol, substituted phenols and substituted amines. ........
and precision.
been developed and validated for simultaneous estimation of Tenofovir disoproxil fumerate (TDF) &
Emtricitabine (EMT) in a combined tablet dosage form. 50% v/v Methanol was used as solvent. The
wavelengths selected for the absorption correction method were 260 nm & 290 nm. The method was found to be
linear between the range of 5-25 μg/ml for TDF and7-35 μg/ml for EMT. The mean percentage recovery was
found in the range of 99.24%-100.42% and 100.03-101.04% for TDF and EMT respectively at three different
levels of standard additions. The precision (intra-day, inter-day) of method were found within limits (RSD
<2%). Thus the proposed method was simple, precise, economic, rapid and accurate and can be successfully
applied for simultaneous determination of TDF and EMT in combined tablet dosage form.
Keywords : Absorbance correction method, Tenofovir disoproxil fumerate, Emtricitabine.
(RP-UPLC) method for the determination of related substances in Metoclopramide
bulk drugs and pharmaceutical dosage form.
Method: The chromatographic separation was achieved using a Waters X-terra RP18
(150 4.6 mm), 3.5 mm particle size column using the gradient program with mobile phase
consisting of solvent A: 30 mM monobasic sodium phosphate and 2.3 mM of pentane-1-
sulphonic acid sodium salt (pH 3.0 buffer) and solvent-B (Acetonitrile). A flow rate of 1.2 mL/
min and UV detector at 273 nm was used. The runtime was 18 min within which Metoclopramide
and its four impurities, ACETYLMETO, ACMA, CLEE and ACME were well separated.
Results and discussion: Thedrugwas subjectedto stress conditions suchasoxidative, acid&base
hydrolysis, thermal and photolytic degradation. Metoclopramide was found to degrade significantly
in photolytic, oxidative&thermal stress conditions and stable in acid, base, hydrolytic&
humidity stress conditions. The major degradation impurities in oxidation and photolytic
degradation were identified by LCMS. The degradation products were well resolved from the
main peak and its impurities, thus proved the stability-indicating power of the method.
Conclusion: The developed method was validated as per ICH guidelines with respect to
specificity, linearity, limit of detection, limit of quantification, accuracy, precision and
robustness. The calibration curves obtained for the four impurities were linear over the
range 0.062e3.040 mg/mL.
Copyright ª 2013, JPR Solutions; Published by Reed Elsevier India Pvt. Ltd. All rights
reserved.
* Corresponding author. Tel.: þ91 4427141358; fax: þ91 4427156816.
E-mail address: prathyusha.pchgs@gmail.com (P. Sowjanya).
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/jopr
chromatography (UPLC) method to determine Lidocaine and its degradation impurities in pharmaceutical
dosage forms.
Method: Chromatographic separation was achieved by gradient elution on Agilent eclipse plus C18 (100x4.6)
mm, and 1.8μm column with potassium dihydrogen phosphate buffer (pH 4.50) and acetonitrile within a short
runtime of 14.0 min. The eluted compounds were monitored at wavelength of 230 nm using photodiode array
(PDA) detector, the flow rate was 1.0 mL/min, and the column oven temperature was maintained at 40 ◦C.
Result: The resolution of Lidocaine and six (potential, bi-products and degradation) impurities was greater
than 2.0 for all pairs of components. The repeatability and intermediate precision, expressed by the RSD, were
less than 1.0%. The accuracy and validity of the method were further ascertained by performing recovery
studies. The specificity of the method was investigated under different stress conditions including hydrolytic,
oxidative, photolytic and thermal as recommended by ICH guidelines. Relevant degradation was found to take
place under oxidative condition.
Conclusion: Method was Robustness against small modification in pH, column oven temperature, flow rate
and percentage of the mobile phase composition was ascertained. All these results provide that the method has
stability indicating properties being fit for its intended purpose; it may find application for the routine analysis
of the related substances of Lidocaine formulations.
Keywords: Ultra Performance Liquid chromatography (UPLC); Lidocaine; Validation; Stress Degradation
products
mainly in the buccal mucosa, labial mucosa, floor of the mouth and tongue. The etiology
for aphthous is still not clear though many predisposing factors like stress, trauma,
immunologically mediated, infectious agents like virus etc., are considered. As the etiopathogenesis
of the disease is multifactorial, treatment mainly aims in symptomatic
management of pain or burning sensation using mainly topical anesthetics or antiseptics.
To facilitate the healing process, various anti-inflammatory and anti-allergic agents are
also tried. A medication which could help in reduction of pain, ulcer size, erythema, ulcer
duration and prevent recurrence is essential to treat the ulcers. The efficacy of Amlexanox
in treatment of aphthous ulcers is tried in various clinical trials. This systematic review
article aims in evaluation of Amlexanox efficacy in satisfying all the demands such as
reduction of pain, ulcer size, ulcer duration erythema and recurrence.
can alter administered drug act on the body. Pharmacology scientists are conducting research to
improve crew health and well-being. Astronauts are not the only ones who benefit from space
medicine research. Space pharmacology research will benefit health care on Earth. Several
medical products have been developed that are space spinoffs, that is practical applications for
the field of medicine arising out of the space program. It is difficult to conclude the optimal drug
regimens in microgravity to ensure safe, effective, and definitive treatment of space travellers.
This study is mainly focused on the health issues in space, space medicine for astronauts,
pharmacokinetic, pharmacodynamics and pharmacotherapeutics in space and medicine spinoffs.
Keywords: Microgravity, space suits, spinoffs
and treat drug-induced liver damage. Chonemorpha fragrans belonging to family
Apocynaceae are used traditionally for their hepatoprotective effect. We wanted to evaluate
the hepatoprotective activity of Chonemorpha fragrans and observe whether synergistic
hepato-protection exists with silymarin. The in vitro antioxidant and in vivo hepatoprotective
effects of alcoholic extract of Chonemorpha fragrans (C. fragrans) root were evaluated in
rats against paracetamol and Isoniazid models. The antioxidant activity of C. fragrans was
assayed and activities were compared to standard antioxidant, ascorbic acid. The results
revealed that the IC50 values of C. fragrans root extract for DPPH, hydroxyl, superoxide
radical scavenging activities were 198.7±0.2, 275.7 ± 0.8 and 177.4±0.4 μg/mL, respectively.
Liver injury was induced by paracetamol (2gm/kg) Isoniazid (100 mg/kg) orally for 14 days.
The two different set of experiments the Chonemorpha fragrans extracts (200 and 400
mg/kg) and silymarin (25 mg/kg) were administrated orally in preventive models. The
Chonemorpha fragrans and silymarin administration prevented the toxic effect of
Paracetamol and Isoniazid the biochemical parameters in preventive model. The present
study concludes that ethanolic extract of Chonemorpha fragrans root has significant
antioxidant and hepatoprotective activity against induced Paracetamol and Isoniazid
hepatotoxicity.
mannitol in using direct compression as well as wet and dry granulation. The effect of the
ratio of the two components, percentage of lubricant and particle size on the properties of
the prepared co-processed excipient has been investigated. Optimal physicochemical
properties of the excipient, from a manufacturing perspective, were obtained using a coprocessed
mannitol- TSP (2:8 w/w) mixture prepared by wet granulation. Disintegration
time, crushing strength and friability of tablets produced by co-processed mannitol- TSP,
using magnesium stearate as a lubricant, were found to be independent of the particle
size of the prepared granules. The inherent binding and disintegration properties of the
compressed co-processed mannitol- TSP are useful for the formulation of poorly
compressible, low and high strength active pharmaceutical ingredients. The ability to coprocess
Tamarind seed polysaccharide (TSP) with crystalline mannitol allows TSP to be
used as a valuable industrial pharmaceutical excipient. The aim of present study was to
formulate and evaluate an oral sustained release tablet of Propranolol hydrochloride to
increase therapeutic effect, reduced frequency of administration and improved patient
compliance. Propranolol HCl tablet was formulated by using co-processed excipients
Tamarind seed polysaccharide and mannitol. Formulations were prepared by varying the
polymer concentration. The optimized formulations were subject to stability testing as per
ICH guidelines.
KEYWORDS- Propranolol HCl, Tamarind seed polysaccharide (TSP), co-processed excipients
readily accessible 4 - (1 – substituted) – 5 - ethoxy carbonyl – 6 - methyl] - 3, 4 –dihydropyrimidine – 2 (1H) – one was investigated in presence of ethanol, substituted phenols and substituted amines. ........
and precision.
been developed and validated for simultaneous estimation of Tenofovir disoproxil fumerate (TDF) &
Emtricitabine (EMT) in a combined tablet dosage form. 50% v/v Methanol was used as solvent. The
wavelengths selected for the absorption correction method were 260 nm & 290 nm. The method was found to be
linear between the range of 5-25 μg/ml for TDF and7-35 μg/ml for EMT. The mean percentage recovery was
found in the range of 99.24%-100.42% and 100.03-101.04% for TDF and EMT respectively at three different
levels of standard additions. The precision (intra-day, inter-day) of method were found within limits (RSD
<2%). Thus the proposed method was simple, precise, economic, rapid and accurate and can be successfully
applied for simultaneous determination of TDF and EMT in combined tablet dosage form.
Keywords : Absorbance correction method, Tenofovir disoproxil fumerate, Emtricitabine.
(RP-UPLC) method for the determination of related substances in Metoclopramide
bulk drugs and pharmaceutical dosage form.
Method: The chromatographic separation was achieved using a Waters X-terra RP18
(150 4.6 mm), 3.5 mm particle size column using the gradient program with mobile phase
consisting of solvent A: 30 mM monobasic sodium phosphate and 2.3 mM of pentane-1-
sulphonic acid sodium salt (pH 3.0 buffer) and solvent-B (Acetonitrile). A flow rate of 1.2 mL/
min and UV detector at 273 nm was used. The runtime was 18 min within which Metoclopramide
and its four impurities, ACETYLMETO, ACMA, CLEE and ACME were well separated.
Results and discussion: Thedrugwas subjectedto stress conditions suchasoxidative, acid&base
hydrolysis, thermal and photolytic degradation. Metoclopramide was found to degrade significantly
in photolytic, oxidative&thermal stress conditions and stable in acid, base, hydrolytic&
humidity stress conditions. The major degradation impurities in oxidation and photolytic
degradation were identified by LCMS. The degradation products were well resolved from the
main peak and its impurities, thus proved the stability-indicating power of the method.
Conclusion: The developed method was validated as per ICH guidelines with respect to
specificity, linearity, limit of detection, limit of quantification, accuracy, precision and
robustness. The calibration curves obtained for the four impurities were linear over the
range 0.062e3.040 mg/mL.
Copyright ª 2013, JPR Solutions; Published by Reed Elsevier India Pvt. Ltd. All rights
reserved.
* Corresponding author. Tel.: þ91 4427141358; fax: þ91 4427156816.
E-mail address: prathyusha.pchgs@gmail.com (P. Sowjanya).
Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/jopr
chromatography (UPLC) method to determine Lidocaine and its degradation impurities in pharmaceutical
dosage forms.
Method: Chromatographic separation was achieved by gradient elution on Agilent eclipse plus C18 (100x4.6)
mm, and 1.8μm column with potassium dihydrogen phosphate buffer (pH 4.50) and acetonitrile within a short
runtime of 14.0 min. The eluted compounds were monitored at wavelength of 230 nm using photodiode array
(PDA) detector, the flow rate was 1.0 mL/min, and the column oven temperature was maintained at 40 ◦C.
Result: The resolution of Lidocaine and six (potential, bi-products and degradation) impurities was greater
than 2.0 for all pairs of components. The repeatability and intermediate precision, expressed by the RSD, were
less than 1.0%. The accuracy and validity of the method were further ascertained by performing recovery
studies. The specificity of the method was investigated under different stress conditions including hydrolytic,
oxidative, photolytic and thermal as recommended by ICH guidelines. Relevant degradation was found to take
place under oxidative condition.
Conclusion: Method was Robustness against small modification in pH, column oven temperature, flow rate
and percentage of the mobile phase composition was ascertained. All these results provide that the method has
stability indicating properties being fit for its intended purpose; it may find application for the routine analysis
of the related substances of Lidocaine formulations.
Keywords: Ultra Performance Liquid chromatography (UPLC); Lidocaine; Validation; Stress Degradation
products
mainly in the buccal mucosa, labial mucosa, floor of the mouth and tongue. The etiology
for aphthous is still not clear though many predisposing factors like stress, trauma,
immunologically mediated, infectious agents like virus etc., are considered. As the etiopathogenesis
of the disease is multifactorial, treatment mainly aims in symptomatic
management of pain or burning sensation using mainly topical anesthetics or antiseptics.
To facilitate the healing process, various anti-inflammatory and anti-allergic agents are
also tried. A medication which could help in reduction of pain, ulcer size, erythema, ulcer
duration and prevent recurrence is essential to treat the ulcers. The efficacy of Amlexanox
in treatment of aphthous ulcers is tried in various clinical trials. This systematic review
article aims in evaluation of Amlexanox efficacy in satisfying all the demands such as
reduction of pain, ulcer size, ulcer duration erythema and recurrence.