LC–ESI-MS Characterization of Degradents of Brivaracetam; Development and Validation of a Stability-Indicating RP-HPLC Method

The planned study demonstrates the validation of the developed simple, precise, and robust stability-indicating assay method by high-pressure liquid chromatography and the identification and characterization of Brivaracetam (BRV) degradants by High-Performance Liquid Chromatography-Tandem Mass Spectrometry. The drug was exposed to a few stressors i.e. acidic, basic, oxidative, thermal, and UV light to study the stability-indicating behavior of the planned method and observed sufficient degradation in the acidic stressor. All separations were done on Hi-Q SiliC-18 (I250 x 4.6mm, 5µm particle size) by isocratic elution flow at 1ml/min. Detection was set at 210nm. All obtained results indicate that the present method is helpful in the quality control (QC) laboratory to the day-to-day investigation of (BRV) for the assay and degradation products. HPLC method development and validation have been done per the current ICH guidelines. The m/z value obtained in LC-MS analysis of the degradant was used to study further fragmentation patterns, structural elucidation of the degradant, and its pathway.