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

Boyka Tsvetkova, Lily Peikova
2013 Journal of Chemical and Pharmaceutical Research   unpublished
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
more » ... ention 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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