Analytical Method Development & Validation for Related Substances Method of Busulfan Injection by Ion Chromatography Method

Author(s)

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

Author's Affiliation

Abstract

A new simple, accurate, precise and reproducible Ion chromatography method has been developed for the estimation of Methane sulfonic acid in Busulfan injectable dosage. 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, LOD and LOQ determination, Accuracy, Method precision, Specificity, 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 85% to 115% of the specification limits.

Keywords

HPLC, Busulfan, Methanesulfonic Acid

Cite This Article

Rewaria, S., Swamy, B. M. V. (2013). Analytical Method Development & Validation for Related Substances Method of Busulfan Injection by Ion Chromatography Method. International Journal for Pharmaceutical Research Scholars (IJPRS), 2(2), 71-78.