Stability Indicating Method Development and Validation for Estimation of Valacyclovir in Pharmaceutical Preparation

Abstract

Valacyclovir is an antiviral drug that is frequently administered to treat herpes simplex and herpes zoster infections. A simple, rapid, and accurate method for quantifying valacyclovir hydrochloride in tablet and bulk form has been developed. Two distinct analysis approaches, UV and HPLC, were developed in the present study for the evaluation of valacyclovir hydrochloride in pharmaceutical preparation. The mobile phase employed in the UV technique was Methanol:10mM KH2PO4 Buffer (50:50) for estimation of the drug at 254nm, and the (VAL) achieved was 99.45%. The method's validation was completed in accordance with ICH Q2 R1 standards, and linearity was found in the 9–45g/ml range with a regression value of 0.997% and RSD values of accuracy, precision, and robustness that were less than 2. In the HPLC method, the estimation of (VAL) was assessed on a Cosmosil C-18 (250mm4.6ID, Particle size: 5) column with Methanol:10mM KH2PO4 Buffer (50:50), 1 ml/min of flow rate, detection wavelength of 254nm, and the time of retention observed to be approximately 5.03 minutes with the assay value of 99.56%. Additionally, the HPLC technique was verified in accordance with ICH standards, and linearity was found in the 10–50g/ml range with a regression coefficient value of 0.998. Precision, accuracy, and robustness all had RSDs that were under 2%. Using Methanol:10mM KH2PO4 Buffer (50:50), the HPLC technique was also used to evaluate forced degradation at 254nm. It is clear from this study that the proposed methods for valacyclovir estimate in pharmaceutical preparation are quick, efficient, and specific. They may also be applied in routine analysis for the quantification of the drug in a dosage form.