Analytical Method Development & Validation for Assay Method of Busulfan Injection by RP-HPLC Method

A new simple, accurate, precise and reproducible RP-HPLC method has been developed for theestimation of Busulfan (1, 4-butanediol dimethanesulfonate) in its injectable dosage. The methoddeveloped is Reverse Phase High Performance Liquid Chromatographic method using suitable C18column (Length: 150mm, Diameter: 4.6mm, Particle size: 3μ) with isocratic elution and a simpleAcetonitrile, Water and Tetrahydrofuran in the ratio of 66:32:2 (v/v/v) respectively as mobile phase. Themethod which is developed is also validated in complete compliance with the current regulatoryguidelines by using well developed analytical method validation techniques and tools which compriseswith the analytical method validation parameters like Linearity, Accuracy, Method precision, Specificitywith forced degradation, System suitability, Robustness, Ruggedness etc. by adopting the currentmethod the linearity obtained is near to 0.999 and thus this shows that the method is capable to give agood detector response, the recovery calculated was within the range of 98% to 102% of thespecification limits.