Quantification of Different drug substances in Pharmaceutical Formulations by Analytical HPLC

Abstract

The present study was conducted to develop and validate an analytical procedure for the determination of Busulfan, Bendamustine Hydrochloride and Clofarabine in Pharmaceutical Formulations. The analytical test attributesand evaluated as per the guidelines of ICH Q2 (R1). The method was validated for the determination of Assay in finished products of Busulfan, Bendamustine Hydrochloride and Clofarabine and the method validation parameters were evaluated for the analytical test attribute Busulfan, Bendamustine Hydrochloride and Clofarabine meets the acceptance criteria. The results obtained were within the specified limits and the samples were analyzed for test item concentration by High Performance Liquid Chromatography.