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development and validation of rp hplc method

This document details the development and validation of a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous quantification of Cinitapride and Pantoprazole, which are used together for gastrointestinal disorders. The method was validated according to ICH guidelines, demonstrating high accuracy, precision, and specificity. The results indicate that this RP-HPLC method is suitable for routine quality control in pharmaceuticals.

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rajeshkumarbasantia
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22 views21 pages

development and validation of rp hplc method

This document details the development and validation of a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous quantification of Cinitapride and Pantoprazole, which are used together for gastrointestinal disorders. The method was validated according to ICH guidelines, demonstrating high accuracy, precision, and specificity. The results indicate that this RP-HPLC method is suitable for routine quality control in pharmaceuticals.

Uploaded by

rajeshkumarbasantia
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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DEVELOPMENT AND VALIDATION OF

RP-HPLC METHOD FOR SIMULTANEOUS


QUANTIFICATION OF CINITAPRIDE AND
PANTOPRAZOLE

Under the guidence of: Prepared by:


Miss. MONALISA PATRA Priyanka Priyadarsani Tripathy
Lecturer, S.P.E.R (Pharmacy) Registration : 20831/2023
Roll Number : 23PHQA010
CONTENTS

 Introduction
 Objective of the Study Review of literature
 Importance of RP-HPLC in Pharmaceutical Analysis
 Drug Profile
 Aim and Objective
 Plan of Work
 Reference
INTRODUCTION
 Reverse Phase High-Performance Liquid
Chromatography (RP-HPLC) is a widely used technique
in pharmaceutical analysis.

 It is essential for the quantification of drugs in various


formulations, ensuring quality control and regulatory
compliance.

 In this study, we focus on developing a validated RP-


HPLC method for the simultaneous estimation of
Cinitapride and Pantoprazole.
OBJECTIVE OF THE STUDY
 The main objectives of this study are:

 To develop an RP-HPLC method for the


simultaneous quantification of Cinitapride and
Pantoprazole.

 To validate the developed method following ICH


guidelines.

 To ensure the method is accurate, precise,


specific, and robust for pharmaceutical quality
control.
IMPORTANCE OF RP-HPLC IN
PHARMACEUTICAL ANALYSIS

 RP-HPLC is crucial in pharmaceutical analysis


because:

 It provides high accuracy and precision in drug


quantification.
 It allows separation of complex mixtures

efficiently.
 It is widely applicable in drug stability testing,

bioavailability studies, and quality control.


CINITAPRIDE – OVERVIEW
 Cinitapride is a prokinetic agent used to treat
gastrointestinal disorders such as gastroesophageal
reflux disease (GERD) and dyspepsia.

 Drug Class: Benzamide derivative

 Mechanism of Action: Acts as a serotonin (5-HT)


receptor modulator, enhancing gastric motility.

 Improves gastric emptying and relieves symptoms of


indigestion.
PANTOPRAZOLE – OVERVIEW
 Pantoprazole is a proton pump inhibitor (PPI) used to
reduce stomach acid production.

 Drug Class: PPI

 Mechanism of Action: Irreversibly inhibits the H+/K+


ATPase enzyme in gastric parietal cells.

 Used for GERD, Zollinger-Ellison syndrome, and peptic


ulcers.
CHEMICAL STRUCTURES OF
CINITAPRIDE & PANTOPRAZOLE
 The molecular structures of Cinitapride and
Pantoprazole are crucial in understanding their
physicochemical properties.

 These properties influence their chromatographic


behavior during HPLC analysis.
NEED FOR SIMULTANEOUS
ESTIMATION

 Cinitapride and Pantoprazole are often prescribed together


for gastrointestinal disorders.

 A simultaneous estimation method ensures quality control,


reduces analysis time, and improves efficiency.

 It is cost-effective compared to individual drug analysis.


RP-HPLC – BASICS

 RP-HPLC is a type of liquid chromatography


where the stationary phase is non-polar, and
the mobile phase is polar.

 It provides better separation for analytes


with different polarities.

 Common solvents include methanol,


acetonitrile, and water.
INSTRUMENTATION &
COMPONENTS
 The RP-HPLC system consists of:

 Mobile Phase: A mixture of solvents (e.g., water,


methanol, acetonitrile).

 Stationary Phase: Typically, a C18 column is used.

 Detector: UV-Vis or PDA detector for drug detection.

 Injector: Introduces the sample into the system.

 Data Processing System: Analyzes and records


chromatographic data.
MOBILE PHASE SELECTION
 The composition of the mobile phase plays a
crucial role in retention time and resolution.

 The selection depends on pH, polarity, and


solubility of the analytes.

 Common solvents include acetonitrile and


methanol in a buffered aqueous solution.
COLUMN SELECTION

 A C18 column is most commonly used for


RP-HPLC.

 Factors influencing column selection:

 Particle size (e.g., 5 µm for better


resolution)

 Column length (e.g., 250 mm for improved


separation)

 Pore size (e.g., 100 Å for small molecules).


CHROMATOGRAPHIC CONDITIONS
 Mobile Phase Composition:
Acetonitrile:Water (60:40)

 Flow Rate: 1.0 mL/min

 Detection Wavelength: 280 nm

 Column Temperature: 30°C

 Retention Times: Cinitapride ~3.5 min,


Pantoprazole ~5.2 min
METHOD VALIDATION – ICH
GUIDELINES
 Validation ensures the developed method
meets regulatory standards.
 ICH Q2 (R1) guidelines define validation

parameters:
 Specificity

 Linearity

 Accuracy & Precision

 Robustness

 System Suitability
RESULTS & DISCUSSION –
CHROMATOGRAMS
 Representative chromatograms show well-
resolved peaks for both drugs.

 Retention times are consistent across


multiple runs.

 No interference from excipients, ensuring


specificity.
RESULTS & DISCUSSION –
VALIDATION DATA
 Linearity: Calibration curves show a
correlation coefficient (R² > 0.999).

 Accuracy: % Recovery within 98-102%.

 Precision: RSD < 2% for intra-day and inter-


day variations.

 Robustness: Small changes in flow rate and


mobile phase do not affect results.
CONCLUSION
 The developed RP-HPLC method is validated
and meets ICH guidelines.

 It is specific, accurate, precise, and robust


for simultaneous estimation of Cinitapride
and Pantoprazole.

 This method is suitable for routine quality


control analysis in pharmaceuticals.
REFERENCES &
ACKNOWLEDGMENTS
 ICH Guidelines Q2 (R1) – Validation of
Analytical Procedures.

 Research articles on RP-HPLC method


development.

 Acknowledgment to lab members and


faculty for support.

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