New Rverse Phase- H.P.L.C Method Development and Validation for the Estimation of in Vemuraafenib in Formulation

Abstract

A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated
for rapid assay of Vemurafenib in tablet dosage form. Isocratic elution at a flow rate of 0.8ml/min was
employed on a symmetry C18 (250×4.6mm, 5μm in particle size) at ambient temperature. The mobile
phase consisted of methanol, Acetonitrile, THF 65:20:15 v/v/v . The UV detection wavelength was
271nm and 20μl sample was injected. The retention time for Vemurafenib was 6.0 min. The percentage
RSD for precision and accuracy of the method was found to be less than 2%. The method was validated
as per the ICH guidelines. The method was successfully applied for routine analysis of Vemurafenib in
tablet dosage form.