Analytical Development Procedure for Determination of Assay in Finished Product of Bendamustine Hydrochloride in Bendamustine Hydrochloride

Abstract

The present study was conducted to develop and validate an analytical procedure for the determination of Bendamustine Hydrochloride in Pharmaceutical Formulations. The analytical test attribute Bendamustine Hydrochloride was evaluated as per the guidelines of ICH Q2 (R1). The method was validated for the determination of Assay in finished product of Bendamustine Hydrochloride Injection and the method validation parameters were evaluated for the analytical test attribute Bendamustine Hydrochloride meets the acceptance criteria. The results obtained were within the specified limits thus, this method was used for the determination of Assay in finished product of Bendamustine Hydrochloride Injection (6mg/mL) and the samples were analyzed for test item concentration by High Performance Liquid Chromatography.