STUDIES ON THE PURITY OF CHINESE MEGESTROL ACETATE: SEPARATION AND IDENTIFICATION OF EPIMERIC ISOMERS OF 6-HYDROXY-6-METHYL-17α-ACETOXY-PROGESTERONE

Two impurities are separated from Chinese megestrol acetate by column chromatography and thin-layer chromatography. On the basis of UV, IR, ¹HNMR, ¹³CNMR spectroscopy and EI mass spectrometry, these two impurities were identified as 6α-hydroxy-6β-methyl-17α-acetoxy-progesterone and its epimeric isomer 6β-hydroxy-6α-methyl-17α-acetoxy-progesterone. we report here the optimal TLC conditions (silica GF₂₅₄, ethyl acetate—toluene=7:3) and the spectral data.