Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF VALSARATN AND HYDROCHLOROTHAIZIDE IN BULK AND COMBINED TABLET DOSAGE FORM BY USING RP-HPLC

Pranita A. Chaudhari*, S. R. Bavaskar and Dr. S. D. Barhate,

Abstract

A Rapid and Precise RP-HPLC Method has been developed and validated for simultaneous estimation of Valsartan (VAL) and Hydrochlorothiazide (HCTZ) in bulk and combined Tablet dosage form. The method was carried out on the chromatographic separation was achieved by isocratic elution technique on (reverse phase) Primesil C18 column (250 mm x 4.6 mm ID, Particle size 5μm), using mobile phase composition of Methanol : Water (0.05%OPA) in the ratio of 80:20 v/v with a flow rate 0.7ml/min. The two wavelengths 246nm and 268 nm were selected for estimation of Valsartan and Hydrochlorothiazide respectively. The retention time of VAL and HCTZ were found to be 4.40 min and 7.88 min respectively. The VAL and HCTZ followed linearity in the concentration range of 32- 60μg/ml and 5-25μg/ml respectively with r²=0.999 for both VAL and HCTZ. The amount of both drugs estimated by the proposed method was found to be in good agreement with labelled claim. The developed analytical validation for precision, accuracy, sensitivity, robustness and ruggedness. The developed method can be used for routine analysis of titled drugs in bulk and combined dosage form.

Keywords: Valsartan and Hydrochlorothiazide, RP-HPLC, Validation.