Bioequivalence assessment of diltiazem preparations by means of discriminant analysis of data from solid-phase extraction and liquid chromatography.
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.
Chaves das Neves
H J
HJ
Departamento de Quimica, Faculdade de Ciencias e Tecnologia, Universidade Nova de Lisboa, Monte da Caparica, Portugal.
Gomes da Silva
M D
MD
Rocha
M P
MP
D000328:Adult; D001682:Biological Availability; D002138:Calibration; D002853:Chromatography, Liquid; D004110:Diltiazem / Q000493:pharmacokinetics*; D016002:Discriminant Analysis; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D015999:Multivariate Analysis; D013810:Therapeutic Equivalency
D004110:Diltiazem