Determination of diminazene aceturate in pharmaceutical formulations by HPLC and identification of related substances by lC/MS

C. Atsriku, D.G. Watson, J.N.A. Tettey, M.H. Grant, G.G. Skellern

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28 Citations (Scopus)

Abstract

A validated, reversed-phase, isocratic high-performance liquid chromatographic method for the simultaneous assay of diminazene aceturate, antipyrine (excipient) and diminazene impurities in pharmaceutical formulations is described. The chromatographic system consisted of a Lichrospher-60 RP-select B column with a mobile phase composition of acetonitrile–methanol–ammonium formate (pH 4.0, 20 mM) (10:10: 80 v/v/v) and UV detection at 254 nm. The method is specific, precise and accurate for the determination of diminazene in the presence of its manufacturing and degradation impurities with a limit of detection and quantification of 50 ng/ml and 10 μg/ml (RSD<3.0%), respectively. The major manufacturing impurity [1-(4 amidino phenyl)3-(4 carbamoyl phenyl)-triazene] and a degradant (p-aminobenzamidine) of diminazene aceturate have been resolved and identified by liquid chromatography/electrospray ionization-mass spectrometry operated in a positive ion mode.
Original languageEnglish
Pages (from-to)979-986
Number of pages8
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume30
Issue number4
DOIs
Publication statusPublished - 2002

Keywords

  • diminazene aceturate
  • HPLC
  • pharmaceutical formulations
  • spectrometry

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