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

Author(s)

Rewaria, S., Swamy, B. M. V.

Author's Affiliation

Abstract

A new simple, accurate, precise and reproducible RP-HPLC method has been developed for the estimation of Busulfan (1, 4-butanediol dimethanesulfonate) in its injectable dosage. The method developed is Reverse Phase High Performance Liquid Chromatographic method using suitable C18 column (Length: 150mm, Diameter: 4.6mm, Particle size: 3μ) with isocratic elution and a simple Acetonitrile, Water and Tetrahydrofuran in the ratio of 66:32:2 (v/v/v) respectively as mobile phase. The method which is developed is also validated in complete compliance with the current regulatory guidelines by using well developed analytical method validation techniques and tools which comprises with the analytical method validation parameters like Linearity, Accuracy, Method precision, Specificity with forced degradation, System suitability, Robustness, Ruggedness etc. by adopting the current method the linearity obtained is near to 0.999 and thus this shows that the method is capable to give a good detector response, the recovery calculated was within the range of 98% to 102% of the specification limits.

Keywords

HPLC, Busulfan, Methanesulfonic Acid

Cite This Article

Rewaria, S., Swamy, B. M. V. (2013). Analytical Method Development & Validation for Assay Method of Busulfan Injection by RP-HPLC Method. International Journal for Pharmaceutical Research Scholars (IJPRS), 2(2), 20-26.