反相高效液相法测定克霉唑栓有关物质  

RP-HPLC determination of the related substances of clotrimazole suppositories.

作　　者：霍静[1] 许小红[2] 

机构地区：[1]四川省妇幼保健院,四川成都610031 [2]成都医学院,四川成都610083

出　　处：《四川医学》2010年第9期1355-1356,共2页Sichuan Medical Journal

摘　　要：目的建立克霉唑栓有关物质的HPLC测定方法。方法色谱柱为Diamonsil C18柱(4.6mm×250mm,5μm),以甲醇-pH4.0磷酸盐缓冲液(70:30)为流动相,流速1.0ml/min,检测波长为220nm,进样量为20μl,柱温40℃。结果克霉唑色谱保留时间约为10min,与其有关物质分离良好。结论该法准确,灵敏度高,可有效地控制该药品有关物质。Objective To establish a method for determination the relative substances of clotrimazole suppositories by RP-HPLC.Methods A C18 column（Diamonsil,4.6mm×250mm,5μm） was used.The mobile phase was acetonitrile-pH4.0 phosphoric acid（70 ： 30）,the speed was 1.0 ml/min,and the wavelength of UV detector was 220 nm,the amount of injection was 20μl,the temperature of column was 40℃.Results The retention time was about 10 minute,and the resolution of clotrimazole with its related compounds was good.Conclusion The method was convenient and accurate,and it can be used to control the related substance of clotrimazole suppositories.

关 键 词：克霉唑栓 有关物质 HPLC 

分 类 号：R927.2[医药卫生—药学]