摘要
采用石英毛细管色谱柱CP62430×0.32×8μm,以6%氰丙基苯-94%二甲基聚硅氧烷为固定相,建立了顶空气相色谱法分析米非司酮中的残留溶剂的方法。结果乙醇的线性范围为101～503ug.mL-1,乙酸乙酯的线性范围为99～495ug.mL-1,正己烷的线性范围为6～29ug.mL-1;其回收率为乙醇100.6%,RSD为1.7%,乙酸乙酯100.4%,RSD为1.6%,正己烷99.8%,RSD为1.0%;最低检测限乙醇为0.12ug.g-1,乙酸乙酯为0.2ug.g-1,正己烷为0.03ug.g-1,色谱峰面积与进样量呈良好的线性关系。该法准确、简便、灵敏,可用于米非司酮原料中的有机溶剂残留量的测定。
CP624 30 × 0.32 × 8 μm capillary column was used to develop headspace gas chromatography for the determination of residual sovent in mifepristone. The linear concentration region of ethanol was 101 - 503ug· mL^-1, ethyl acetate was 99 -495ug· mL^-1, n-hexane was 6 - 29ug· mL^-1 , the relative recovery of ethanol was 100.6% with RSD 1.7% , ethyl acetate was 100.4% with RSD 1.6%, n -hexane was 103.0% with RSD 1.0% , the lowest detective concentration was 50ug· mL^-1 for ethanol and 50ug· mL^-1 for ethyl acetate and 3ug · mL^-1 for n -hexane. The method are simple ,accurate and sensitive. This method is suitable for determination of residual solvent in mifepristone.
关键词
顶空气相色谱法
残留溶剂
米非司酮
headspace gas chromatography
residual sovent
mifepristone
