VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ALISKIREN AND VALSARTAN IN TABLET DOSAGE FORM

Abstract

A simple, precise and accurate stability indicating RP-HPLC method has been developed and

Subsequently validated for simultaneous estimation of Aliskiren (ALN) and Valsartan (VAL) from their combination dosage form. Water’s HPLC equipped with UV-Visible and Diode Array detectors, with Empower -2 software was used. Column used was XTerra® RP8, 5 μm, 100 mm × 4.6 mm i.d., at ambient temprature.Mobile phase consisting of 0.05M Ammonium Acetate and 0.5% TEA buffer having pH 5.5and Acetonitrile in the ratio of 68:32 v/v at a flow rate of 1.0 mL/ min and UV detection was carried out at 238 nm and 271 nm for ALN and VAL, respectively. ALN, VAL and their combined dosage form were exposed to thermal, photolytic, oxidative, acid-base hydrolytic stress conditions, the stressed samples were analyzed by proposed method. Peak purity results suggested no other co-eluting, interfering peaks from excipients, impurities, or degradation products due to variable stress condition, and the method is specific for the estimation of ALN and VAL in presence of their degradation products and impurities within 6 minutes. The retention time of Aliskiren and Valsartan were 1.98 and 4.03 minutes respectively. The method was found linear over the range of 1-20 μg per ml for Aliskiren and 1.6-240 μg per ml for Valsartan. The proposed method was validated as per the ICH and USP guidelines.