Degradation Products Profiling of Myco phenolate Mofetil using UHPLC and High Resolution Bench-Top Mass Spectrometer

摘要

Thermal and hydrogen peroxide degradation study of Mycophenolate Mofetil API at pH 2.0, 3.5, 6.0, and 8.2 were carried out. Rapid, confident degradation product profiling were achieved by utilizing benchtop high resolution mass spectrometer Q Exactive coupled with UHPLC system: (1) The high resolution accurate mass measurement (HRAM) full scan spectra allow quick profiling through accurate information of elemental composition of degradants; (2) Information-rich higher energy collision diss ociation (HCD) MS/MS spectra facilitate confident structural elucidation of degradants; (3) Comprehensive degradation product identification was enabled by positive/negative switching in full scan and MS/MS modes; (4) Data analysis software Mass Frontier great improved the speed and confidence of structural elucidation of degradants. The functionalities of Q Exactive bench-top Orbitr ap MS enable fast and efficient degradants profiling in an all-in-one UHPLC/HR-MS/MS platform, which can significantly increase the throughput of degradant identification in drug discovery and development.