SEPARATION AND IDENTIFICATION OF IMPURITIES IN MIFEPRISTONE

In this paper we presented details of metnods for the TLC and HPLC separation ofmifepristone and its impurities. The results showed that Chinese mifepristone contained five impurities.The major one was isolated by sillca gel column chromatography and thin layer chromatography. Onbasis of its UV, IR, EIMS and ¹HNMR spectral analysis and by comparison with reference substance,it was identified as (11β, 17β)-11-(4-methylamino) phenyl-17-hydroxy-17-(1-propyny)-estra-4,9-dien-3-one.Meanwhile, TLC analysis indicated that French mifepristone contained the sameimpurity.