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 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.
Gazdag
M
M
Chemical Works of Gedeon Richter Ltd., Budapest, Hungary.
Babják
M
M
Brlik
J
J
Mahó
S
S
Tuba
Z
Z
Görög
S
S
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
D011239:Prednisolone; C073319:Mazipredone