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Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF AMLODIPINE BESLYLATE AND VALSARTAN IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

Ch.Umashankar*, K.Mangamma and G.Manikumar

ABSTRACT

A simple, specific, accurate and precise reverse phase high pressure liquid chromatographic method has been developed for the simultaneous determination of Valsartan and Amlodipine besylate in tablet dosage form by using Hypersil BDS C18, 250mm X 4.6 mm, 5μm column. The samples were analyzed by using 0.05M sodium dihydrogen phosphate: water (80: 20) v/v as a mobile phase at the flow rate of 1.0 ml/min in isocratic mode and detection wavelength is 220 nm. Both the drugs were eluted within 5 minutes and gave sharp peaks with high theoretical plate count and low tailing factor. The retention time for Valsartan and Amlodipine besylate was found to be 2.39 and 3.33 min respectively. The validation was carried according to ICH guidelines. Calibration curve was linear with correlation coefficient of 0.998 and 0.998 over a concentration range of 40μg/mL-280μg/mL and 2.5-17.5μg/ml for Valsartan and Amlodipine besylate respectively. The percent recovery was 99.71 for Valsartan and 99.78 for Amlodipine besylate indicating accuracy and reliability of method. So the method can be used for estimation of combination of these drugs in tablet dosage form.

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