Method for detecting related substances in perampanel bulk drug and application thereof

The invention relates to a method for detecting related substances in a perampanel bulk drug and application of the method. Belongs to the technical field of pharmaceutical analysis. According to the method, a high performance liquid chromatography method is adopted, and a DAD detector is used for detecting a sample. A chromatographic column with octadecylsilane chemically bonded silica as a filler is adopted, an ammonium acetate aqueous solution and an acetonitrile solution in a certain proportion are adopted as mobile phases, and gradient elution is carried out. Through comprehensive methodology verification, the method can be used for effectively separating and determining the related substances of the perampanel raw material medicine in the process, so that the quality of the perampanel raw material is controlled. 本发明涉及一种吡仑帕奈原料药中有关物质的检测方法及其应用。属于药物分析技术领域。本发明采用高效液相色谱法，以DAD检测器对样品进行检测。以十八烷基硅烷键合硅胶为填料的色谱柱，采用一定比例的乙酸铵水溶液及乙腈溶液为流动相，进行梯度洗脱。经过全面的方法学验证，本方法可有效分离和测定本工艺吡仑帕奈原料药的有关物质，进而对吡仑帕奈原料进行质量控制。