米非司酮阴道环的含量及有关物质测定方法的研究  

Determination of mifepristone and its related substances in drug loaded vaginal ring

作　　者：段雪艳[1] 张莹[1] 陈凯[2] 李青山[2] 王介东[3] 宁美英[1] 

机构地区：[1]国家人口计生委科学技术研究所药物与医用材料研究中心,北京100081 [2]山西医科大学药学院,太原030001 [3]国家人口计生委科学技术研究所生殖生理研究室,北京100081

出　　处：《中国新药杂志》2013年第5期598-601,共4页Chinese Journal of New Drugs

基　　金：国家十二五科技支撑计划(2012BAI31B00)

摘　　要：目的:建立米非司酮(RU486)阴道环的含量及其有关物质的高效液相色谱测定方法。方法:色谱柱为Diamonsil C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(0.05%三乙胺)(75∶25),流速为1.0mL.min-1,检测波长为304 nm。结果:米非司酮与相关杂质及降解产物均分离良好,空白辅料对测定无干扰。米非司酮在0.5～12.0μg.mL-1范围内具有良好的线性关系(r=0.999 9),最低检测限为10 ng.mL-1,平均回收率为100.5%。结论:本方法用于米非司酮阴道环的质量评价,操作简便,定量准确,专属性强,灵敏度高,重复性好。Objective： To develop an HPLC method for determining the content of mifepristone and related substances in vaginal ring. Methods： The separation and determination were accomplished on a Diamonsil C18 （250 mm × 4.6 mm, 5μm） column with UV detection at 304 nm. The mobile phase consisted of methanol and water （75：25 ） containing 0.05% triethylamine at a flow rate of 1.0 mL. min-1 Results ： The good separation was obtained for mifepristone and its related substances, and their determination was not interfered by the excipients.The calibration curve of mifepristone had acceptable linearity in the range of 0.5 - 12.0 μg· mL^-1 （ r = 0. 999 9 ）. The lowest limit of determination was 10 ng·mL^-1 The average recovery was 100.5%. Conclusion： The procedure of pretreatment was simple, and this method is accurate and reliable with a good reproducibility. It can be used in the quality evaluation of mifepristone vaginal ring.

关 键 词：米非司酮 阴道环 含量测定 有关物质 高效液相色谱法 

分 类 号：R979.21[医药卫生—药品]