靶向NS4B抑制剂安非合韦的有关物质测定  

Determination of Related Substances of a Targeted NS4B Inhibitor Amphihevir by HPLC

作　　者：陶鑫 袁红[2] 焦丹丹 

机构地区：[1]常州寅盛药业有限公司,江苏常州213003 [2]苏州大学附属儿童医院,江苏苏州215000

出　　处：《化工时刊》2017年第8期7-10,共4页Chemical Industry Times

基　　金："十二五"新药创制重大专项资助项目(2012ZX09103-101-079)

摘　　要：目的安非合韦为针对丙肝NS4B靶点的1类新药,采用HPLC法测定安非合韦的有关物质。方法采用Thermo BDS HYPERSIL C18(4.60×250 mm,5.0μm,用等度洗脱的方式,流动相为0.1%磷酸水溶液∶乙腈=5∶5,波长为210 nm,柱温40℃,流速1.0 m L·min^(-1)。结果安非合韦的峰能与相邻杂质峰完全分离。安非合韦定量限为0.029 98μg·m L^(-1),最低检出限为0.008 99μg·m L^(-1)。重复性和中间精密度良好。样品溶液在24 h内稳定。结论该方法可用于检测安非合韦的有关物质。Objective：Amphihevir is a novel targeted NS4B inhibitor. The object is to establish a HPLC method for the determination of related substances. Method：Thermo BDS HYPERSIL C18 （4.60 × 250 mm, 5.0 μm column was used. The mobile phase was 0.1% phosphoric acid aqueous solution to acetonitrile （5：5 ） with isocratic elution. The UV detection wavelength was 210 nm, the column temperature was 40 ℃ and the flow rate was 1.0 mL· min -1 Results：Amphihevir could be separated effectively. LOQ was 0. 029 98 μg · mL^-1 and LOD was 0. 008 99 μg · mL-l. Repeatability and intermediate precision were all right. The solution was stable in 24 hConclusion： The meth- od can be used to determine the related substances of Amphihevir

关 键 词：高效液相色谱法 NS4B 丙肝药物 安非合韦 有关物质 

分 类 号：O657.72[理学—分析化学] TQ460.72[理学—化学]