Abstract

A new, simple, accurate, precise and reproducible reverse phase high performance liquid chromatography method was developed and fully validated for the simultaneous estim ation of amlodipine besylate, olmesartan medoxamil and hydrochlorothiazide in tablet dosage form isocratically using acetonitrile: methanol: phosphate buffer pH - 3.0 (48:12:40 % v/v/v) as mobile phase and Prontosil C - 18 column (4.6 x 250 mm, 5 μ particle si ze) as stationary phase and chromatogram was recorded at 232 nm at a flow rate of 1.2 mL/min. The calibration curves obtained were linear (r 2 = 0.99 98 ) over the concentration range of 5 - 25 µg/ml, 5 - 25 µg/ml and 5 - 25 µg/ml for amlodipine besylate, olmesarta n medoxamil and hydrochlorothiazide respectively. A run time of 7.0 min utes for each sample made it possible to analyze more than 200 samples per day. The developed methods were validated according to ICH guidelines and values of accuracy, precision and ot her statistical analysis were found to be in good accordance with the prescribed values therefore t he method can be used for routine monitoring of amlodipine besylate, olmesartan medoxamil and hydrochlorothiazide in ind ustry in the assay of bulk drug and d osage form.

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