SIMULTANEOUS ESTIMATION OF TELMISARTAN AND AMLODIPINE BESYLATE IN PHARMACEUTICAL DOSAGE FORM BY RP - HPLC

Paul Richards M, Bharat Kumar D, Mohammad Y, Karunakar Reddy, Siddhartha B

The chromatographic analysis was performed on ODS symmetry C18 column (150 × 4.6 mm, 5 μ particle size) with mobile phase consisting of acetonitrile and phosphate buffer (pH 4.0) in the ratio of 60:40 v/v, at a flow rate of 1.2 mL/min and eluents monitored at 237 nm. The method was validated for linearity, accuracy, precision, robustness and application for assay as per International Conference on Harmonization (ICH) guidelines. The retention times of amlodipine besylate and telmisartan were 2.633 and 5.600 min, respectively. The calibration curves of peak area versus concentration, which was linear from 2.5-15 μg/mL for amlodipine besylate and 20-120 μg/mL for telmisartan, had regression coefficient (r2) greater than 0.999. The method had the requisite accuracy, precision, and robustness for simultaneous determination of amlodipine besylate and telmisartan in tablets. The proposed method is simple, economical, accurate and precise, and could be successfully employed in routine quality control for the simultaneous analysis of amlodipine besylate and telmisartan in tablets.