Stability indicating UPLC-MS/MS method for quantification and identification of cefepime and its degradants in API

Abstract

An analytical method was developed and validated for determining stability studies of the drug cefepime (CFP) by Ultra Performance Liquid Chromatography -Tandem Mass Spectrometer (UPLC-MS/MS). In this research, Ultra Performance Liquid Chromatography (UPLC) C18 ethylene hybrid column was used. About 0.2% formic acid in the water and acetonitrile (ACN), in 20:80 v/v ratios, was used as the mobile phase with a 0.15 ml/minute flow rate. In multiple reaction monitoring modes, positive electrospray ionization (ESI) was used. The chromatogram of standard Cefepime (CFP) was found to have a retention time of 0.82 ± 0.02 minute. The degradation of CFP was tested under different stress conditions and the method was validated to meet the International Conference on Harmonization of Technical Requirement for Registration of Pharmaceuticals for Human Use guidelines. The retention time of the forced degraded solutions of CFP was found to be 0.76, 0.83, 0.81, and 0.82 minutes for forced acidic, oxidation, thermal, and neutral conditions, respectively. The MS/MS spectra for CFP at 179.15 and 241.33 ± 0.06 in different stress conditions (except basic) with retention times at 0.90 ± 0.02 and 0.84 ± 0.10 minutes indicate Cefepime degradant 1 (CD1) and Cefepime degradant 2 (CD2), respectively. The MS/MS spectra for CFP basic degradant (CD1) in the basic medium were obtained at an m/z ratio of 179.15. The research findings conclude that CFP was unstable with partial degradations in all conditions, and complete degradation in basic medium.