HPLC法测定氢溴酸高乌甲素的有关物质  

HPLC determination of related substances in Lappaconite Hydrobromide

作　　者：陈露[1] 蔡姗英[1] 鲁秋红[1] 

机构地区：[1]海南省药品检验所,海南海口570216

出　　处：《广东药学院学报》2013年第5期518-521,共4页Academic Journal of Guangdong College of Pharmacy

摘　　要：目的建立高效液相色谱法测定氢溴酸高乌甲素原料药的有关物质。方法采用依利特Hypersil BDS C18柱(5μm,4.6 mm×250 mm)为分析柱,流动相为0.04 mol·L-1KH2PO4-甲醇-乙腈(体积比68∶17∶15),流速为1.0 mL·min-1,检测波长为252 nm。结果氢溴酸高乌甲素杂质分离良好,最低检测限为0.5 ng。结论该方法简便、快速、重复性好,可以用于氢溴酸高乌甲素的有关物质测定。Objective To establish a method for the determination of related substances in Lappaconite Hydrobromide. Methods The separation was performed on Hypersil BDS C18 （5 μm,4. 6 mm × 250 mm） with mobile phase of 0. 04 mol. L^-1 KH2PO4- methanolaeetonitrile （68 ： 17 ： 15 ） at the flow rate of 1.0 mL .min ^-1, and the detective wavelength was 252 nm. Results The impurities of Lappaconite Hydrobromide were well separated and the LOD was 0. 5 ng. Conclusion The HPLC method is convenient, fast and has good repeatability. This method can be adopted to detect the related substances in Lappaconite Hydrobromide.

关 键 词：高效液相色谱法 氢溴酸高乌甲素 有关物质 杂质检测 

分 类 号：R927.2[医药卫生—药学]