Impurity Profiling of Novel Oxazolidinone Antibacterial Agent: WCK 4086

Abstract

WCK 4086 is new antibacterial drug being developed to treat infections caused by Gram positive bacteria. This study describes development of mass spectrometry (MS) compatible reversed phase liquid chromatographic method for separation, identification and quantification of the related compounds in WCK 4086. Four process related compounds and seven degradation products (DPs) were separated and structurally identified with the use of liquid chromatography tandem mass spectrometry. Three process-related compounds were synthesized and characterized using MS and nuclear magnetic resonance spectrometry. Acid/base hydrolysis produced three DPs and oxidation produced four DPs. Method validation activity was performed to increase the acceptability of the developed method. The method was precise and accurate; accuracy exceeded 97.04% with a precision of less than 5.55%. The impurities could be detected as low as 0.05 µg mL−1. The methodology was used for the batch release and stability studies of the WCK 4086 used in the preclinical studies.