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.

Abstract

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 294nm. Perampanel and its impurities were well-separated within a run time of 7min. To show the stability-indicating power of the method, forced degradation studies were performed on bulk samples of perampanel as per ICH prescribed stress condition using acid, base, hydrolytic, oxidative and photolytic degradation conditions. The degradation products were resolved from main peak and its impurities. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. This method was also applied for assay and related substances determination of perampanel in bulk and pharmaceutical dosage form.