A Simple, Sensitive, Specific Reversed-Phase Ultra Performance Liquid Chromatographic UV Method For Estimation Of Paratoluenesulfonic Acid In Valacyclovir Hydrochloride Sample

Abstract

A simple, sensitive, accurate and precise Reversed Phase-UPLC- method was developed for quantitave determination of paratoluenesulfonic acid (PTSA) content in Valacyclovir Hydrochloride pharmaceutical drug substance. The RP-UPLC method
was developed by using Acquity UPLC BEH C18 100mm x 2.1mm, 1.7µ column and mobile phase consisted of Tetra butyl ammonium hydrogen phosphate buffer and Acetonitrile in the ratio of 79:21v/v, the column temperature was maintained at 25º C. The mobile phase flow rate maintained at 0.20ml/min. The retention time of PTSA is about 8.6 min. The linearity in the concentration range of 0.1ppm to 4.0ppm with R2 =0.999 (n=5), Limit of detection (LOD) and limit of Quantification (LOQ) values were 0.03ppm and 0.10ppm for PTSA respectively with respect to test concentration of 2.0mg/ml. The validation study was carried out as per international conference on harmonization (ICH) guidelines. The proposed method was found to be specific, precise, linear and accurate and can be applied to determine paratoluenesulfonic acid in commercial batch samples of Valacyclovir Hydrochloride.