Zeitschrift für Bioanalyse und Biomedizin

Quantification of 4-Oxiranyl Methoxy-9h-Carbazole a Genotoxic Impurity in Carvedilol Drug Substances by Lc-Ms

Abstract

M. Srinivasa Rao, Sumathi V. Rao, U.K.Ray, G.Sri Siva Kumar, Hemant Kumar Sharma and K.Mukkanti

LC-MS multiple reaction monitoring (MRM) method had been evaluated for the determination of the very low level of 4-Oxiranylmethoxy-9H-Carbazole in drug substances such as Carvedilol (U.S. Pharmacopoeia (USP), 32NF-27,British pharmacopoeia (BP), 2009, Martindale 35 th edition) This 4-Oxiranylmethoxy-9H-Carbazole have been identi fi ed as potential genotoxic impurity. LC-MS was found to be more promising and the limit of quanti fi cation was 15 μ g/gm.