Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF VALACYLOVIR HYDROCHLORIDE BY UV AND HPLC

Ashwini S. Pundkar* and Vilas A. Arsul

ABSTRACT

A Ultra-Violet (UV) and High Performance Liquid Chromatography (HPLC) have been developed for the estimation of Valacyclovir Hydrochloride in bulk drug and pharmaceutical dosage form. The method is carried out using C18 column 150×4.6mm i.e. particle size 5μm and mobile phase consisting of Methanol: Water (70:30), at flow rate of 0.8ml/min. The column temperature is ambient. Eluents were monitored by UV detector set at 252nm. The method was statistically validated in terms of linearity, accuracy, precision and robustness in accordance with ICH guidelines Linear regression analysis data for the calibration plot showed that there was a linear relationship between response and concentration in the range of 10μgm/ml To 50μgm/ml and the correlation coefficient is 0.9998. Literature survey reveals analytical methods for the estimation of Valacyclovir Hydrochloride from pharmaceutical dosage forms and also in biological fluids. The proposed method was found to be simple, precise, accurate, rapid and reproducible for the estimation of Valacyclovir Hydrochloride in bulk drug and tablet.

Keywords: Valacyclovir hydrochloride, Method Development, UV and HPLC validation.