HPLC法测定奥赛博司原料药中有关物质的含量  

Determination of the Related Substances in Aosaibos Crude Drug by HPLC

作　　者：陈毓杰[1] 刘培勋[1] 洪阁[1] 李琪[1] 

机构地区：[1]中国医学科学院北京协和医学院放射医学研究所,天津市300192

出　　处：《中国药房》2009年第19期1495-1497,共3页China Pharmacy

基　　金：天津市科技计划项目(07ZCKFSH00200)

摘　　要：目的:建立以高效液相色谱法测定奥赛博司原料药中有关物质含量的方法。方法:色谱柱为SunFireTMRP C18,流动相为磷酸盐缓冲溶液(pH3.05)-乙腈(8∶2),流速为1mL.min-1,检测波长为220nm,进样量为20μL,柱温为室温。结果:3批原料药经破坏试验后奥赛博司主峰与其它杂质峰均分离较好,有关物质含量均小于1.19%。结论:本方法简便、灵敏度高,可用于奥赛博司有关物质的含量检测。OBJECTIVE： To determine the contents of the related substances in Aosaibos crude drug by HPLC. METH- ODS： The determination was carried out on a SunFireTM RP C18 column with mobile phase consisted of phosphate buffer solution （pH 3.05） - acetonitrile （8 ： 2） at a flow rate of 1 mL ·min -5. The detection wavelength was set at 220 nm; The sample size was 20μL and column temperature was set at room temperature. RESULTS： The main peak and the impurity peaks of 3 batchs of Aosaibos crude drug were well- separated. The contents of the related substances were all lower than 1.19%. CONCLUSION： The determination method is simple, sensitive and applicable for the content determination of the related substances of Aosaibos.

关 键 词：高效液相色谱法 奥赛博司 有关物质 含量 

分 类 号：R979.1[医药卫生—药品] R927.2[医药卫生—药学]