Analysis of sterodis - part 53 - Estimation of impurity profiles of drugs and related materials - Part 18. Impurities and degradation products of mazipredone

Reversed-phase HPLC methods using C-18 and C-8 columns as well as various i socratic and gradient systems with aqueous ammonium acetate, methanol and a cetonitrile are described for the separation of the impurities of mazipredo ne (11 beta,17-dihydroxy-21-(4-methyl-1-piperazinyl)-pregna-1,4-diene-3,20- dione hydrochloride). These methods were used also for the estimation of th e hydrolytic and oxidative degradation pathways of mazipredone in 0.1 M hyd rochloric acid and sodium hydroxide at 80 degrees C. With the aid of HPLC-( APCI)-MS and HPLC-diode-array UV techniques 15 impurities and degradation p roducts have been identified. (C) 1998 Elsevier Science B.V. All rights res erved.