European Journal of Biomedical and Pharmaceutical Sciences

DEVELOPMENT AND VALIDATION OF REVERSED-PHASE HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AZILSARTAN MEDOXOMIL AND AMLODIPINE BESYLATE IN TABLET DOSAGE FORM

Nita Yadav*, Anju Goyal and Rajesh Yadav

ABSTRACT

An isocratic RP-HPLC method was developed and validated for simultaneous estimation of Azilsartan medoxomil and Amlodipine besylate in tablet dosage form. The chromatographic separation was carried out on C18 Inertsil ODS column (250 X 4.6 mm, 5μm particle size) with mixture of 0.1% TFA and ACN in ratio of 75:25, v/v as a mobile phase; at a flow rate of 1.0 mL/min. UV detection was performed at 245 nm. The retention time was found to be 4.626 min and 2.222 min for azilsartan medoxomil and amlodipine besylate, respectively. Calibration plots were linear over the concentration range of 4-20 μg/mL and 1-5 μg/mL for azilsartan medoxomil and amlodipine besylate, respectively. The method was validated for linearity, accuracy, precision, repeatability, LOD and LOQ. The proposed method was successfully used for quantitative estimation of azilsartan medoxomil and amlodipine besylate. Percentage recovery within the limit of 98-102 % and low relative standard deviation confirm the suitability of the proposed method for routine estimation of azilsartan medoxomil and amlodipine besylate in tablet dosage form.

Keywords: RP-HPLC, Azilsartan medoxomil, Amlodipine besylate.