High-performance liquid chromatography of steroidal drugs

The high-performance liquid chromatographic (HPLC) analysis of progesterone, oxyprogesterone capronate and dehydroacetoxyprogesterone has been carried out successfully using so-called "test impurities". The quantitative and qualitative analysis of related compounds was studied by normal-phase HPLC with a UV detector (254 nm) using ethyl acetate-chloroform (98.5:1.5) and ethyl acetate-hexane (20:80) as solvent systems. Preparative separations of impurities by HPLC were investigated, subsequent structural identification being achieved by mass, UV and IR spectrometry. The method may be applied to the control of the quantitative purity of steroids in drugs and complex mixtures.