HPLC法测定氟康唑胶囊的有关物质  

Determination of Related Substances in Fluconazole Capsules by HPLC

作　　者：王沪凯[1] 刘菲[2] 

机构地区：[1]沈阳市第七人民医院,沈阳110003 [2]辽宁省食品药品检验所

出　　处：《中国药师》2012年第7期982-984,共3页China Pharmacist

摘　　要：目的:建立HPLC测定氟康唑胶囊中的有关物质。方法:色谱柱采用Diamonsil C_(18)(250 mm×4.6 mm,5μm);流动相为乙腈-0.63 g·L^(-1)甲酸铵溶液(20:80);流速为1.0 ml·min^(-1);检测波长为260 nm。结果:氟康唑与其降解产物在该色谱条件下能够有效分离;最低检出量为12.5 ng。结论:本方法简便、准确,灵敏度高,专属性强,可用于氟康唑胶囊中有关物质的测定。Objective： To establish an HPLC method for the determination of the related substances in fluconazole capsules. Method： Diamonsil C ls column （250 mm ×4.6 mm, 5 μm）was used. The mobile phase consisted of acetonitrile-0.63 g· L-1 ammonium formate solution（20： 80）. The flow rate was 1.0 ml · min-1 and the detection wavelenghth was 260 nm. Result： Fluconazole and its related substances could be separated effectively by the method with the lowest detection limit of 12.5 ng. Conclusion： The method is convenient, accurate, sensitive and specific. It is suitable for the determination of the related substances in fluconazole capsules.

关 键 词：高效液相色谱 氟康唑胶囊 有关物质 

分 类 号：R927.2[医药卫生—药学]