Abstract A simple, rapid, accurate and precise RP-HPLC method was developed and validated for simultaneous estimation of Azilsartan medoxomil and Amlodipine besylate in synthetic mixture. The chromatographic separation was carried out on Hypersil ODS C18 column (250×4.6 mm; 5µ) with mixture of 0.2% ortho-phosporic acid in water :acetonitrile (35:65% v/v) as a mobile phase; at a flow rate of 1.0 mL/min. UV detection was performed at 232 nm. The retention time was found to be 5.496 min and 3.255 min for Azilsartan medoxomil and Amlodipine besylate, respectively. Calibration plots were linear over the concentration range of 80.3-120.5 µg/mL and 20.2-30.2 µg/mL of both Azilsartan medoxomil and Amlodipine besylate, respectively. The method was validated for linearity, accuracy, precision, recovery, repeatability, LOD and LOQ. The proposed method was successfully used for quantitative analysis of Azilsartan medoxomil and Amlodipine besylate used for hypertension. No interference from the components of pharmaceutical dosage form was observed. Good percentage recovery and low relative standard deviation confirm the suitability of the proposed method for routine estimation of Azilsartan medoxomiland Amlodipine besylatein tablet dosage form.
Keywords RP-HPLC, Azilsartan medoxomil, Amlodipine besylate.