论文部分内容阅读
目的采用HPLC法测定Febuxostat原料药中的有关物质。方法采用Agilent Eclipse plus C_(18)色谱柱,以0.05%磷酸溶液-乙腈(40∶60)为流动相,检测波长220 nm,流速1.0 m L·min~(-1),柱温40℃。结果在建立的色谱条件下,Febuxostat与其有关物质的分离良好(R>1.5),杂质A、B、C的相对校正因子分别为1.344、1.588、2.157。结论所用方法操作简便、灵敏度高、专属性强,可用于Febuxostat中有关物质的检查。
Objective To determine the related substances in Febuxostat API by HPLC. Methods Agilent Eclipse Plus C 18 column with 0.05% phosphoric acid - acetonitrile (40:60) was used as the mobile phase. The detection wavelength was set at 220 nm and the flow rate was 1.0 m L · min -1. The column temperature was 40 ℃. Results Under the established chromatographic conditions, the separation of Febuxostat from its related substances was good (R> 1.5). The relative correction factors of A, B and C were 1.344, 1.588 and 2.157, respectively. Conclusions The method used is simple, sensitive, and specific, and can be used for the related substances inspection in Febuxostat.