Tablet Formulation and Development of a Validated Stability Indicating HPLC Method for Quantification of Valsartan and Hydrochlorthiazide Combination

This study was aimed to develop valsartan/ hydrochlorothiazide tablet formulation and to develop a stability indicating HPLC method for their analysis in raw materials and in its final dosage form according to the ICH guidelines. Film coating tablets containing valsartan and hydrochlorothiazide were developed. A gradient HPLC method was performed; the flow rate was 1.5 ml/min, injected volume 20μL, the mobile phases consist of two solvent: Solvent A (0.20 M ammonium acetate, adjusted to pH 5.6 with glacial acetic acid) and Solvent B (acetonitrile) and UV detection was carried out at 265nm. Valsartan and hydrochlorothiazide and their combined dosage form were exposed to thermal, oxidative, acid-base hydrolytic stress conditions, the stressed samples were analyzed. The method was validated with respect to linearity, precision, accuracy, system suitability, and robustness. The used method is specific for the estimation of valsartan and hydrochlorothiazide in presence of their degradation products and impurities. The method was linear over the range of 2.5–32μg/mL and 17.5-224μg/mL for valsartan and hydrochlorothiazide respectively. The mean recoveries were 100±2% for valsartan and hydrochlorothiazide respectively. The percentage of relative standard deviation (%RSD) was found to be less than critical value. Our developed analytical method is a stability indicating, economical and easy method which is useful in the quality control of valsartan and hydrochlorothiazide in tablet dosage forms.

International Journal of Pharmacy & Pharmaceutical Sciences;Jul2012, Vol. 4 Issue 3,
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