Evaluation of Perampanel in the Presence of its Degradation Products and Process-Related Impurities by Validated Stability-Indicating Reverse Phase High Performance Liquid Chromatography Method.

A novel stability-indicating isocratic reverse phase high-performance liquid chromatographic method was developed for the quantitative determination of perampanel in the presence of degradation products and its process-related impurities. Good resolution was achieved between the peaks corresponding to process-related impurities and degradation products from the analyte using Shim-pack GIST C18 column with mobile phase, potassium dihydrogen phosphate (pH 2.5; 30 mM)-acetonitrile (45: 55, v/v) at a wavelength of 294 nm.