title: Estimation of impurity profiles of drugs and related materials Part 18. Impurities and degradation products of mazipredone.
abstract: Reversed-phase HPLC methods using C-18 and C-8 columns as well as various isocratic and gradient systems with aqueous ammonium acetate, methanol and acetonitrile are described for the separation of the impurities of mazipredone (11beta,17-dihydroxy-21-(4-methyl-1-piperazinyl)-pregna-1,4-diene- 3,20-dione hydrochloride). These methods were used also for the estimation of the hydrolytic and oxidative degradation pathways of mazipredone in 0.1 M hydrochloric 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 products have been identified.
authors.affiliation: Chemical Works of Gedeon Richter Ltd., Budapest, Hungary.
authors.forename: M
authors.initials: M
authors.lastname: Gazdag
authors.forename: M
authors.initials: M
authors.lastname: Babják
authors.forename: J
authors.initials: J
authors.lastname: Brlik
authors.forename: S
authors.initials: S
authors.lastname: Mahó
authors.forename: Z
authors.initials: Z
authors.lastname: Tuba
authors.forename: S
authors.initials: S
authors.lastname: Görög
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D006863:Hydrogen-Ion Concentration; D013058:Mass Spectrometry; D015394:Molecular Structure; D011239:Prednisolone / Q000031:analogs & derivatives* / Q000737:chemistry / Q000378:metabolism
chemical_list: D011239:Prednisolone; C073319:Mazipredone