UPLC Method for Simultaneous Determination of Valsartan & Hydrochlorothiazide in Drug Products

Abstract

A new, simple, precise and stability-indicating UPLC (Ultra Performance Liquid Chromatography) method was developed and validated for the simultaneous determination of anti-hypertensive drug Valsartan (VAL) and Hydrochlorothiazide (HCTZ) in combined dosage forms. The method was developed using Kromasil eternity C-18 column (50 mm×2.1 mm, 3.5 μm) with isocratic elution. Triethylamine buffer (0.1% v/v) and methanol (75:25 v/v) were used as mobile phase with 0.6 mL min-1 flow rate at room temperature. The detection wavelength was fixed at 225 nm; the run time was within 2 min. The method was validated in terms of linearity, accuracy and reproducibility. Calibration plots were linear over the range of 7-13 μg/ml for HCTZ and 56-104 μg/ml for VAL. Recovery was in the range of 98-102% with the relative standard deviation of less than 2% for both drugs. The limit of detection and the limit of quantification for the valsartan were found to be 0.8 and 2.4 μg/ml respectively and for hydrochlorothiazide 0.12 and 0.36 μg/ml respectively. The proposed method was also suitable for determination of VAL & HCTZ in bulk and pharmaceutical dosage forms.