[Separation and identification of impurities in mifepristone]

In this paper we presented details of methods for the TLC and HPLC separation of mifepristone 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. On basis of its UV, IR, EIMS and 1HNMR spectral analysis and by comparison with reference substance, it was identified as (11 beta, 17 beta)-11-[(4-methylamino)phenyl]-17-hydroxy-17-(1-propyny)-estra-4 ,9-dien-3 - one. Meanwhile, TLC analysis indicated that French mifepristone contained the same impurity.