DEVELOPMENT, VALIDATION AND APPLICATION OF A CAPILLARY ELECTROPHORESIS METHOD FOR CAPTOPRIL ASSAY IN DRUGS

serigne omar sarr

Abstract


Faced with the scourge of counterfeiting medicines, notably therapeutic failure, assessing the quality of drugs by means of simple methods is more than ever a necessity in Africa. This is the reason why a capillary electrophoresis method for the quality control of captopril was developed, validated, and applied to assess the quality of captopril-based medicines sold in the market place of Dakar.

The quantitative performance of the method was evaluated by using the total error approach, coupled with the accuracy profile as graphical decision-making tool. The validation criteria evaluated were selectivity, linearity, precision, trueness, limit of detection and limit of quantification. Chlorpheniramine served as internal standard.

The method proved to be linear (R2>0,99), precise (RSD≤ 5%), accurate with limit of detection ≤ 13 mg/l and limit of quantification ≤39 mg/l. The method, which has a duration of less than three minutes, proved to be efficient and therefore can be used routinely.

The validated method was applied to control the quality of eight samples of captopril-based medicines which appeared to be globally satisfying.


Keywords


Capillary electrophoresis; method validation; captopril; quality control

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URN: https://pmindexing.com/journals/index.php/IJCPA/issue/view/urn:pmi:jr:0011ijcpa.v5i1.13822

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