DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND INDAPAMIDE IN COMBINED DOSAGE FORM

Jinay Shah, Parul Parmar, Mandev Patel
unpublished
Two simple, accurate, rapid and precise UV spectrophotometric methods have been developed for simultaneous estimation of Amlodipine Besylate and Indapamide in combined tablet formulation. Amlodipine Besylate and Indapamide at their respective λmax 237nm and 240 nm shows linearity in a concentration range of 5-25 μg/ml and 2-10 μg/ml respectively. The methods employed were (A) Absorbance ratio and (B) Area under curve (AUC). Method-A involves measurement of absorbance at 310.0nm (iso-absorptive
more » ... oint) and 237.0 nm (λmax of Amlodipine Besylate). Method-B involves measurement of area at two wavelength range 232.0-242.0 nm and 235.0-245.0 nm. The linearity for Amlodipine Besylate and Indapamide were found over the concentration range of 5-25 μg/ml and 2-10 μg/ml respectively. Both the methods were found to be rapid, specific, precise and accurate, can be successfully applied for the routine analysis of Amlodipine Besylate and Indapamide in bulk, and combined dosage form without any interference by the excipients. The method was validated according to ICH guidelines.
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