Stability Indicating Analytical Method Development and Validation for Simultaneous Estimation of Valsartan and Hydrochlorothiazide in Tablet Dosage Form

A simple, sensitive, precise and specific Reverse Phase High Performance Liquid Chromatographic method was developed and validated for the determination of Valsartan and Hydrochlorothiazide in bulk and tablet dosage form. It was found that the excipient in the tablet dosage form does not interfere in the quantification of active drug by proposed method. The HPLC separation was carried out by reverse phase chromatography by Hypersil BDS C-18 (150 x 4.6 mm) column with a mobile phase composed of water: Acetinitrile: OPA in the ratio of 95:5:1(M.P-A) and Acetinitrile: water: OPA in the ratio of 95:5:1(MP-B) in Gradient mode at a flow Rate of 1.5ml/min. The detection was monitored at 225nm. The calibration curve for valsartan and HCTZ was linear from 50-300 μg/ml and 3.7-22.5 μg/ml respectively. The proposed method has adequate sensitivity, reproducibility and specificity for the determination of Valsartan and HCTZ.