ABSTRACT

A simple, accurate and precise stability indicating RP-HPLC method has been developed and subsequently validated for quantitative estimation of Bendamustine Hydrochloride for injection. The proposed method is done by using column Zorbax SB-C18,5?,250x4.6mm maintained at 8 ºC temperature. The optimum mobile phase consisted of ACN and triflouro acetic acid buffer in which mobile phase A is in the ratio of 90:10 v/v and mobile phase B in the ratio of 50:50 v/v, effluent flow rate monitored at 1.0 ml/min and UV detection was done at 230 nm by diode array detector. The method was validated according to ICH guidelines. It was found to be linear, precise, accurate and reproducible. Bendamustine Hydrochloride for injection was exposed to acid, alkali, hydrogen peroxide, thermal and UV conditions, then the stressed samples were analyzed by the proposed method. There were no interfering peaks from degradation products and impurities due to variable stress conditions and the proposed method is specific for the quantitative estimation of Bendamustine Hydrochloride for injection in the presence of their degradation products also. The method can be successfully applied in quality control of bulk manufacturing. Keywords: Bendamustine Hydrochloride; Quantitative estimation; Forced degradation studies; RP-HPLC
Publication date: 01/10/2022

https://ijbpas.com/pdf/2022/October/MS_IJBPAS_2022_6435.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.10.6435