Analytical Method Development and Validation for Assay Method for Quantification of Busulfan in Pharmaceutical Formulations of by HPLC Method.

[摘要] A new simple, accurate, precise and reproducible HPLC method has been developed for the estimationof Busulfan (1,4-butanediol dimethanesulfonate) in its injectable dosage.A mixture water, acetonitrile andtetrahydrofuran at 30:65:5 (V/V/V) ratios were prepared and used as mobile phase. The method was validatedas per the ICH guidelines. The method was validated for the determination of Assay in finished product ofBusulfan Injection and the method validation parameters were evaluated for the analytical test attributeBusulfan meets the acceptance criteria. The results obtained were within the specified limits thus, this methodwas used for the determination of Assay in finished product of Busulfan Injection (6mg/mL).Thus, the proposedHPLC method can be successfully applied for the routine quality control analysis of formulations.

[学科分类] 工程和技术（综合）

[关键词] HPLC;Busulfan;validation;mutation;anti-neoplastic.