HPLC检查非布司他原料药中的有关物质  

Determination of the related impurities in Febuxostat by HPLC

作　　者：崔婷[1] 张露[2] 戴光琴 张道林[4] 蒋心惠[1] 

机构地区：[1]重庆医科大学药学院,重庆400016 [2]四川大学华西医院,四川成都610041 [3]巫山县人民医院,重庆404700 [4]重庆医药工业研究院有限责任公司,重庆400061

出　　处：《华西药学杂志》2017年第2期217-219,共3页West China Journal of Pharmaceutical Sciences

摘　　要：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 determin the related substances in Febuxostat by HPLC. METHODS An Agilent Eclipse plus ClS column（250 mm ×4.6 mm,5 μm） was used with a mobile phase consisting of 0.05% phosphoric acid- acetonitrile（40 ： 60） at the flow rate of 1.0 mL- min-1. The detection wavelength was 220 nm, and the temperature was 40 %. RESULTS Under the optimum condition, the Febuxostat and its related substances could be separated well. The relative correction factors of impurities A, B and C with Febuxostat were 1. 344,1. 588 and 2. 157, respectively. CONCLUSION The established method is sensitive, effective, reproducible and easy to handle, which can be used for the determinating of the related substances in Febuxostat.

关 键 词：非布司他 高效液相色谱 有关物质 原料药 检查 相对校正因子 相对保留时间 紫外检测器 

分 类 号：R917[医药卫生—药物分析学]