Abstract

Analytical method development and validation of simultaneous determination of Amlodipine Besylate, Valsartan and Hydrochlorthiazide in oral dosage form (tablets) by RP-HPLC technique

A simple, rapid, accurate, specific and sensitive RP-HPLC method has been developed and validated for the simultaneous estimation of Hydrochlorothiazide, Amlodipine Besylate and Valsartan in pharmaceutical oral dosage form (Tablets). The Chromatographic separation was performed on Hypersil BDS C18 column (250mm×4.6mm, particle size of 5μm) using a mobile phase of Water: Acetonitrile: Tri-Fluoroaetic acid in 55:45:0.1, at a flow rate of 1.0ml/min at an ambient temperature with detection wavelengths at 265, 237 and 265nm respectively for Hydrochlorothiazide, Amlodipine Besylate and Valsartan. The retention times was found to be 3.241, 6.836 and 9.634min respectively. The Linearity for Hydrochlorothiazide, Amlodipine Besylate and Valsartan was found in the concentration range of 6.25-18.75mcg/ml, 5-15mcg/ml and 80-240mcg/ml and correlation coefficient was found to be 0.9991, 0.9993 and 0.9988 respectively. The percentage purity of Hydrochlorothiazide, Amlodipine Besylate and Valsartan was found to be 99.52, 100.50 and 99.78% w/v respectively. The proposed method has been validated for accuracy, precision, linearity, range, system suitability and specificity were within the acceptance limit according to ICH guidelines and the developed method can be successfully employed for the routine quality analysis in pharmaceutical oral dosage form (tablets).


Author(s): Karthik Kandikattu

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