1M. Rajavardhan Reddy*, 2Dr. R. Suresh, 3Dr.K. Kannan
1Research Scholar, Annamalai University, Tamil Nadu, India
2Department of Pharmaceutical Chemistry, Annamalai University, Tamil Nadu, India
3Head of the Department, Pharmaceutical Sciences, Annamalai University, Tamil Nadu, India
A B S T R A C T
Genotoxic impurities (GTIs) in pharmaceuticals are of increasing concerns to both pharmaceutical industries and regulatory agencies due to their carcinogenic potency for humans. Practical guidance with respect to the analytical determination of diverse classes of GTIs is currently lacking in the literature. This article provides an industrial perspective with regard to the analysis of GTIs that are commonly encountered during drug development. Determination of these impurities at ppm levels requires highly sensitive analytical methodologies, such as LC/MS, LC-MS/MS, and RP-LC. The present review emphasized on the various methods used for the detection and quantification of genotoxic impurities.
Keywords: Imatinib Mesylate, genotoxic impurities, assay, method validation, anticancer drugs.