Estimation of impurity profiles of drugs and related materials Part 15. Identification of minor impurities in cimetidine

Zs Halmos, Cs Szántay, J. Brlik, A. Csehi, K. Varga, P. Horváth, M. Kislaki, Gy Domány, A. Nemes, S. Görög

Research output: Article

19 Citations (Scopus)

Abstract

Besides several known impurities in cimetidine, two additional compounds at levels below 0.1% were detected by ion-pair reversed-phase high-performance liquid chromatography (HPLC). The impurities were isolated from crude cimetidine using normal-phase preparative HPLC. 1H and 13C NMR and mass spectrometric investigations revealed the structures of the impurities to be 2,5-bis[(N'-cyano-N''-methyl)guanidinoethylthiomethyl]-4- methylimidazole (VII) and 1,8-bis[(N'-cyano-N''-methyl)guanidino]-3,6-dithiaoctane (VIII). These structures were verified by synthesis of the impurities and comparison of the spectra and chromatographic (HPLC and TLC) retention data of the isolated and synthesized materials.

Original languageEnglish
Pages (from-to)1-5
Number of pages5
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume15
Issue number1
DOIs
Publication statusPublished - okt. 1996

ASJC Scopus subject areas

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

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