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    Validation Report

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    Mohammed Zubair
    1. The report describes validation of a UV spectrophotometric method for analysis of Tirix 10mg tablets. 2. The method was validated for precision, accuracy, and linearity. Precision studies showed %RSD values within acceptance criteria. 3. Accuracy studies at multiple concentration levels provided average recovery of 99.77% with %RSD of 0.418, meeting criteria.

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    Validation Report

    Uploaded by

    Mohammed Zubair
    176 views4 pages
    1. The report describes validation of a UV spectrophotometric method for analysis of Tirix 10mg tablets. 2. The method was validated for precision, accuracy, and linearity. Precision studies showed %RSD values within acceptance criteria. 3. Accuracy studies at multiple concentration levels provided average recovery of 99.77% with %RSD of 0.418, meeting criteria.

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    1. The report describes validation of a UV spectrophotometric method for analysis of Tirix 10mg tablets. 2. The method was validated for precision, accuracy, and linearity. Precision studies showed %RSD values within acceptance criteria. 3. Accuracy studies at multiple concentration levels provided average recovery of 99.77% with %RSD of 0.418, meeting criteria.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    176 views4 pages

    Validation Report

    Uploaded by

    Mohammed Zubair
    1. The report describes validation of a UV spectrophotometric method for analysis of Tirix 10mg tablets. 2. The method was validated for precision, accuracy, and linearity. Precision studies showed %RSD values within acceptance criteria. 3. Accuracy studies at multiple concentration levels provided average recovery of 99.77% with %RSD of 0.418, meeting criteria.

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    You are on page 1of 4

    Document code: Issue status: Effective date:

    Page 1 of 4
    QP/QC/11 01 01-10-2008
    ANALYTICAL METHOD VALIDATION REPORT

    Product: TIRIX 10mg TABLET Review No: 01


    Testing Technique: UV-Vis Spectroscopy Reporting Date: 10-10-2008

    TITLE NAME DESIGNATION SIGNATURE

    Author: Hameed ur Rehman Sr. Q.C Analyst

    Validation Analyst: Sajjad ur Rehman Q.C Analyst

    Reviewed By: Muhammad Saleem Sr. Q.C Analyst

    Approved By: Shiraz Khan Q.C Manager


    Document code: Issue status: Effective date:
    Page 2 of 4
    QP/QC/11 01 01-10-2008
    ANALYTICAL METHOD VALIDATION REPORT

    SUMMARY OF REPORT:
    The report describes the validation of analytical method of Tirix 10mg tablets (QP/QC/01/WI-046). The method
    has been validated in terms of Precision, Accuracy and Linearity. The data obtained in the validation process
    complies the acceptance criteria. So, it is concluded that the method is reliable and can be used for the assay of
    Tirix 10mg tablets. The summary of validation results is shown in the Table 1.

    Validation Results Summary


    No Validation Parameter Acceptance Criteria Results
    1 Precision
    1.1 Precision of System RSD < 1.5% 0.124
    1.2 Precision of Method
    1.2.1 Repeatability RSD < 2.0% 0.226
    1.2.2 Reproducability RSD < 2.0% 0.230
    Recovery 98 to 102% 99.77
    2 Accuracy
    RSD < 2.0% 0.418
    3 Linearity Corelation Coefficeint > 0.997 0.9999

    Table 1

    1. PRECISION:

    1.1 Precision of the system:


    A standard solution of 0.01mg per ml of Cetirizine in 0.1N HCl is prepared and the absorbance is checked on UV-Visible
    Spectrophotometer at 231nm. Six consecutive readings of the solution are taken. The relative standard deviation for the obtained
    values is calculated.
    Comments: The relative standard deviation meets the criteria (less than 1.5%). The results and calculations are given in Table 2.

    REPLICATES ABSORBANCE
    Replicate 1 0.441
    Replicate 2 0.441
    Replicate 3 0.442
    Replicate 4 0.441
    Replicate 5 0.442
    Replicate 6 0.442
    CALCULATIONS
    Mean 0.442
    Std dev 0.00055
    RSD % 0.124

    Table 2
    Document code: Issue status: Effective date:
    Page 3 of 4
    QP/QC/11 01 01-10-2008
    ANALYTICAL METHOD VALIDATION REPORT

    1.2 Precision of method:


    1.2.1 Repeatability:
    Five standard solutions of the same concentration (0.01mg per ml) of Cetirizine were prepared in 0.1N HCl by independent weighing
    each time. The relative standard deviation for the obtained values is calculated.
    Comments: The relative standard deviation meets the criteria (less than 2%). The results and calculations are given in Table 3.

    REPLICATES ABSORBANCE
    Replicate 1 0.444
    Replicate 2 0.442
    Replicate 3 0.442
    Replicate 4 0.444
    Replicate 5 0.443
    CALCULATIONS
    Mean 0.443
    Std dev 0.00100
    RSD % 0.226

    Table 3

    1.2.2 Reproducibility (Intermediate Precision):


    A homogenous sample is analyzed by three different analysts. The relative standard deviation of the results is calculated.
    Comments: The relative standard deviation meets the criteria (should not exceed the 4% level).

    RESULT
    ANALYST CETIRIZINE
    (mg/Tab)
    Muhammad Saleem 10.07
    Sajjad ur Rehman 10.07
    Hameed ur Rehman 10.03
    CALCULATIONS
    Mean 10.057
    Std dev 0.02309
    RSD % 0.230

    Table 4

    2. ACCURACY:
    Five different solutions were prepared as per procedure given for accuracy in SOP QP/QC/11/WI-001. After analysis of the samples,
    the relative standard deviation and recovery is calculated.
    Comments: The percentage recovery and the relative standard deviation meet the qualifying criteria (Recovery: 98 ~ 102% & RSD: ≤
    2%).
    Document code: Issue status: Effective date:
    Page 4 of 4
    QP/QC/11 01 01-10-2008
    ANALYTICAL METHOD VALIDATION REPORT

    SAMPLE CONCENTRATION (mg/ml)


    REPLICATES 0.005 0.0075 0.01 0.0125 0.015
    ABSORBANCE
    Replicate 1 0.219 0.328 0.440 0.545 0.652
    Replicate 2 0.220 0.329 0.442 0.545 0.652
    Replicate 3 0.219 0.329 0.438 0.546 0.651
    Replicate 4 0.220 0.327 0.440 0.545 0.651
    Replicate 5 0.217 0.327 0.436 0.545 0.651
    Replicate 6 0.219 0.327 0.439 0.546 0.652
    CALCULATIONS
    Mean 0.219 0.328 0.439 0.545 0.652
    Standard value 0.438 0.438 0.438 0.438 0.438
    Assay (% ) 50.00 74.85 100.27 124.51 148.74
    Recovery (% ) 100.00 99.80 100.27 99.60 99.16
    Average recovery (% ) 99.77
    Standard deviation 0.417
    RSD (% ) 0.418

    Table 5

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