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. Perampanel and its impurities were well-separated within a run time of 7 min. 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.

中文翻译：

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采用经验证的稳定性指示反相高效液相色谱法评价存在降解产物和工艺相关杂质的吡仑帕奈

建立了一种新的稳定性指示等度反相高效液相色谱方法，用于在降解产物及其工艺相关杂质存在下定量测定吡仑帕奈。使用 Shim-pack GIST C18 色谱柱和流动相、磷酸二氢钾 (pH 2.5; 30 mM)-乙腈 (45:55, v/v ) 波长为 294 nm。Perampanel 及其杂质在 7 分钟的运行时间内被很好地分离。为了显示该方法的稳定性指示能力，按照 ICH 规定的应力条件，使用酸、碱、水解、氧化和光解降解条件，对 perampanel 的大块样品进行了强制降解研究。降解产物从主峰及其杂质中分离出来。所开发的方法根据 ICH 指南在特异性、线性、检测限、定量限、准确性、精密度和稳健性方面进行了验证。该方法也适用于散装和药物剂型中吡仑帕奈的含量测定和有关物质的测定。