Quantification of Busulfan in Pharmaceutical Formulations by Analytical HPLC

The present study was conducted to validate an analytical procedure for the Quantification of Busulfan in Pharmaceutical Formulations. The analytical test attribute Busulfan was evaluated as per the guidelines of ICH Q2 (R1). It is a new simple, accurate, precise and reproducible HPLC method has been developed for the estimation of Busulfan (1,4-butanediol dimethanesulfonate) in its inject able dosage. Thus, the proposed HPLC method can be successfully applied for the routine quality control analysis of formulations. A mixture water, acetonitrile and tetrahydrofuran at 30:65:5 (V/V/V) ratios were prepared and used as mobile phase. Citation: V. Tejeswara Rao, Ch. Venkata kishore, K. balaji, K.Raghu Babu. "Quantification of Busulfan in Pharmaceutical Formulations by Analytical HPLC." Global Research and Development Journal For Engineering 6.3 (2021): 18 - 23.