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RP-HPLC法测定米非司酮片中的有关物质
引用本文:李俊,林建雄.RP-HPLC法测定米非司酮片中的有关物质[J].中国药师,2009,12(7):900-902.
作者姓名:李俊  林建雄
作者单位:1. 天津市轩宏医药技术有限公司,天津,300384;深圳市资福药业有限公司
2. 深圳市资福药业有限公司
摘    要:目的:建立米非司酮片有关物质检查的RP-HPLC法。方法:采用Kromasil C18(150mm×4.6mm,5μm)色谱柱;以甲醇-水-三乙胺(75:25:0.05)为流动相;检测波长:304nm;柱温:30℃。结果:米非司酮的最低检出限为0.1μg,米非司酮与有关物质分离良好。结论:方法能灵敏、能有效地进行有关物质检测。

关 键 词:高效液相色谱法  米非司酮片  有关物质

Determination the Related Substances of Mifpristone Tablets by RP-HPLC
Li Jun,Lin Jianxiong.Determination the Related Substances of Mifpristone Tablets by RP-HPLC[J].China Pharmacist,2009,12(7):900-902.
Authors:Li Jun  Lin Jianxiong
Affiliation:Li Jun, Lin Jianxiong (1. Tianjin Xuanhong Medicine and Pharmacy Technology Co. LTD. , Tianjin 300384, China;2. Shenzhen Jifu Pharmaceutical Co. LTD. )
Abstract:Objective: To establish'a RP-HPLC method for determination the related substances of mifpristone tablets. Method: The Kromasil C ls column (150 mm × 4. 6mm,5μm) was used, the mobile phase consisted of methanol-water-tfiethylamine(75:25:0. 05) ;the detection wavelength was 304nm and the column temperature was 30℃. Result: The limit of detection was 0.1 ug for mifpristone. the mifpristone and related substances completely separated. Conclusion: The method is sensitive and reliable, It is suitable for determination the related substances of mifpristone tablets.
Keywords:HPLC  Mifpristone tablets  Related substances
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