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.

Issue

2011 Volume-01

Article Subject

Biotechnology

Keywords

Vemurafenib RP-HPLC, UV detection, 271 nm, recovery, precise.

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