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Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Amlodipine Besilate and Hydrochlorothiazide in Combined Dosage Form

Angshuman Biswas, Asit Kumar De, Ayan Kumar Dey

Abstract


A new simple, accurate, rapid and precise RP-HPLC method has been developed for the estimation of Amlodipine besilate and Hydrochlorothiazide in combined tablet dosage form. The chromatographic estimation was achieved on a Thermo-Fischer Scientific C8 Column(250mm×4.6mm,5.0μm particle size) using the mobile phase-Solution A(0.7%v/v solution of Triethylamine in water ,pH3.0), Acetonitrile and Methanol in the ratio of 40:25:35,at a flow rate of 1.0 ml/min, UV detection wavelength was 237nm and Column was maintained at ambient temperature. The retention time of Amlodipine besilate and Hydrochlorothiazide were 7.6 and 2.9 respectively. Quantification and Linearity was achieved over the concentration range of 10-50 μg/ml for Amlodipine and 20-60 μg/ml for Hydrochlorothiazide. The method was validated for specificity, linearity, accuracy, precision, LOD,LOQ and robustness as per ICH guideline.

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