Estimation of impurity profiles of drugs and related materials Part 18. Impurities and degradation products of mazipredone

  • J Pharm Biomed Anal. 1998 Sep 1;17(6-7):1029-36. doi: 10.1016/s0731-7085(98)00068-5.
M Gazdag  1 ,  M Babják ,  J Brlik ,  S Mahó ,  Z Tuba ,  S Görög
Affiliations
  • 1. Chemical Works of Gedeon Richter Ltd., Budapest, Hungary.
PMID: 9884192 DOI: 10.1016/s0731-7085(98)00068-5
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.

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