HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHIC METHOD FOR QUANTITATIVE ESTIMATION OF VALACYCLOVIR HYDROCHLORIDE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

Girija B. Bhavar*, Kiran B. Aher, Ravindra S. Thorat, Sachin J. Kakad, Sanjay S. Pekamwar

ABSTRACT

A simple, sensitive, precise and specific high-performance thin-layer chromatographic (HPTLC) method for the determination of valacyclovir both in bulk drug and pharmaceutical dosage form was developed and validated. The method employed aluminium plates precoated with silica gel G60 F254 as the stationary phase. The solvent system consisted of n-butanol: methanol:Water in the proportion of 3:1:1, v/v/v. This solvent system was found to give compact spots for valacyclovir with Rf value 0.22 ± 0.01. Densitometric analysis of valacyclovir was carried out in the absorbance mode at 254 nm. Linear regression analysis showed good linearity (r2 =0.998) with respect to peak area in the concentration range of 100–700 ng/spot. The method was validated for precision, limit of detection (LOD), limit of quantitation (LOQ), accuracy and specificity. Statistical analysis proved that the method is repeatable and specific for the estimation of the said drug.

Keywords: Valacyclovir, HPTLC, Method Development, ICH guidelines.