Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Aliskiren, Amlodipine and Hydrochlorthiazide in Tablet Dosage Form (original) (raw)

2014

Abstract

A simple, sensitive, and precise RP-High Performance Liquid Chromatography (HPLC) method for the simultaneous estimation of Aliskiren (ALS), Amlodipine (AML) and Hydrochlorothiazide (HCTZ) combined dosage form has been developed and validated. The components were well separated using Hypersil BDS, 250 x 4.6 mm, 5 column using Acetonitrile:1ml TEA in 1000 potassium phosphate buffer 0.01M (40:60% v/v) as mobile phase at a flow rate of 1.0 mL/min. The eluents were detected at 228 nm using UV detector. The retention time of HCTZ 3.3 min, ALS was found to be 5.9 min and that of AML was 8.0 min. The linearity was observed between 6.25-37.5µg/mL, 75-450µg/mL and 2.5-15µg/mL for HCTZ, ALS and AML respectively. The marketed dosage form was analysed by using the developed method. The mean recoveries were 100±2% for three compounds. The method was validated for system suitability, specificity, linearity, accuracy, precision, ruggedness and robustness as per ICH guidelines and the results were...

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