Development and validation of RP-HPLC method for simultaneous determination of Amlodipine Besylate and Hydrochlorothiazide in pharmaceutical dosage form

Boyka G. Tsvetkova and Lily P.

Abstract

A simple, rapid and prcise method was developed for the simultaneous determination of Amlodipine Besylate (AML) and Hydrochlorothiazide (HTZ) in tablet dosage form. Analysis was performed on a C8 (250 mm x 4.6 mm, 5 μm) column with acetonitrile:0.5 M phosphate buffer (pH 3) 60:40 (v/v) as mobile phase, a flow rate 1.0 ml/min and column temperature 30ºC. Quantitation was achieved with UV detection at 272 nm. Both the drugs were well resolved on the stationary phase and the retention times were found to be 3.09 min for AML and 7.41 min for HTZ. The calibration curves were linear in the concentration range of 5.00-40.00 μg/ml for AML and 12.50-100.0 μg/ml for HTZ. Intra- and inter-day relative standard deviations for both the components were <2.0%. The method was found to be accurate, with recoveries in the range 99.28 % – 100.3 %. The method proposed proved to be specific, rapid and accurate for the quality control of both drugs in pharmaceutical preparation.

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