高效液相色谱法测定米非司酮片的含量和含量均匀度

Determination of content and its evenness in Mifepristone tablets by HPLC

目的建立高效液相色谱法测定米非司酮片的含量和含量均匀度的方法。方法采用Zorbax XDB C18色谱柱(250mm×4.6mm,5μm),流动相为甲醇-水-三乙胺(75∶25∶0.05),流速1.0mL·min-1,检测波长为306nm。结果米非司酮在1.0979～43.916μg·mL-1(r=0.9999)范围内具有良好的线性,回收率为100.03%,RSD为0.22%。结论该方法操作简便,结果准确,重现性好,可用于米非司酮片的质量控制。

OBJECTIVE To establish a method for component and its evenness of Mifepristone tablets by HPLC.METHODS The HPLC was performed with C18 column（250mm×4.6mm,5μm）,and the mobile phase consisted of Methanol-water-three ethylamine-glacial acetic acid（75∶25∶0.05）;at flow rate of 1.0mL·min-1.The UV detective wavelength was 306 nm.RESULTS Mifepristone well showed linear relationship within the range of 1.0979～43.916μg·mL-1（r=0.9999）.The recovery rate was 100.03% and the RSD was 0.22%.CONCLUSION The method is simply operated with accurate and reliable results.It is available for the quality control of the Mifepristone tablets.