Bioequivalence assessment of diltiazem preparations by means of discriminant analysis of data from solid-phase extraction and liquid chromatography

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Abstract

A solid-phase extraction technique for sample clean-up coupled with a new LC procedure is reported for the assay of diltiazem in plasma. The use of disposable cartridges provides selective extraction and easy automation. A new LC system based on LiChrospher® RP 60 Select B columns is described. For routine analysis, the procedure provides a rapid simultaneous clean-up of several samples prior to chromatography and reproducible recoveries over a concentration range of 10-800 ng. The procedure was used to analyse the plasma samples from a bioequivalence study of three commercial diltiazem preparations. The pharmacokinetic parameters in 12 healthy male volunteers were determined and the assessment of bioequivalence was conducted by discriminant analysis.

Original languageEnglish
Pages (from-to)941-947
Number of pages7
JournalJournal Of Pharmaceutical And Biomedical Analysis
Volume9
Issue number10-12
DOIs
Publication statusPublished - 1 Jan 1991

Keywords

  • bioequivalence
  • Diltiazem preparations
  • discriminant analysis.
  • liquid chromatography
  • solid-phase extraction

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