Estimation of impurity profiles of drugs and related materials. Part 19: Theme with variations. Identification of impurities in 3-oxosteroids

S. Görög, M. Babják, G. Balogh, J. Brlik, F. Dravecz, M. Gazdag, P. Horváth, A. Laukó, K. Varga

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Due to the varied reactions leading to the 3-oxo group in steroids and the reactivity of its environment, a large number of impurities related to this group are formed during the reaction steps and the degradation studies. In this paper the experiences from the authors laboratory with the 3-oxo-related impurities in 19-nor-4-ene-3-oxosteroids (norgestrel, norethisterone, nandrolone, its esters and Nestorone(TM)) as well as corticosteroids (prednisolone, mazipredone, etc) are presented. The impurities include saturated 3-ones, 1-ene-3-ones, 5(10)-ene-3-ones, 3-deoxo and 3-ethinyl-3,5-diene derivatives, 6-ene, 8(14)-ene, 6,8(14)-diene, 6-hydroxy (α and β), 10β-hydroxy and 6-one derivatives in 4-ene-3-oxosteroids and 8(9)-ene, 9(11)-ene, 11α-hydroxy, 11-oxo and 4-ene-3-one derivatives in 11β-hydroxy-1,4-diene-3-oxosteroids. The chromatographic, spectroscopic and hyphenated techniques used in this study include TLC, GC, HPLC with diode array UV detector, GC-MS, LC-MS and NMR methods. Copyright (C) 1998 Elsevier Science B.V.

Original languageEnglish
Pages (from-to)511-525
Number of pages15
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume18
Issue number4-5
DOIs
Publication statusPublished - Dec 1 1998

Keywords

  • 3-Oxo steroids
  • Impurity profiles
  • Mazipredone
  • Nandrolone esters
  • Nestorone(TM)
  • Norethisterone
  • Norgestrel
  • Prednisolone

ASJC Scopus subject areas

  • Analytical Chemistry
  • Pharmaceutical Science
  • Drug Discovery
  • Spectroscopy
  • Clinical Biochemistry

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