目的 :本文对尼美舒利原料药有关物质方法学进行了研究,并建立了尼美舒利有关物质检查的HPLC方法。方法:本文用十八烷基硅烷键合硅胶作为填充剂,以浓度为0.1%的磷酸溶液以及乙腈作为流动相,检测的波长为230nm,流速为1.0m/min,色谱柱的温度与室温一致。结果:通过研究与分析发现,运用本文中的方法,可以有效控制尼美舒利的质量,而且该方法专属性强、准确度高,重现效果极佳,适用于尼美舒利原料药有关物质方法学的研究。 OBJECTIVE: In this paper, the methodology of the related substances of nimesulide APIs was studied, and the HPLC method of nimesulide related substances was established. Methods: In this paper, octadecylsilane bonded silica gel was used as a filler. The concentration of 0.1% phosphoric acid solution and acetonitrile were used as the mobile phase. The detection wavelength was 230 nm and the flow rate was 1.0 m / min. . Results: Through the research and analysis, it is found that the method of this article can effectively control the quality of nimesulide, and the method has the advantages of high specificity, high accuracy and excellent reproducibility, and is suitable for the application of the nimesulide drug substance Material Methodology.