DETERMINATION OF THE ENANTIOMERS OF NISOLDIPINE IN HUMAN PLASMA USINGHIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY ON A CHIRAL STATIONARY-PHASE AND GAS-CHROMATOGRAPHY WITH MASS-SELECTIVE DETECTION

Citation
R. Heinig et al., DETERMINATION OF THE ENANTIOMERS OF NISOLDIPINE IN HUMAN PLASMA USINGHIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY ON A CHIRAL STATIONARY-PHASE AND GAS-CHROMATOGRAPHY WITH MASS-SELECTIVE DETECTION, Journal of chromatography B. Biomedical applications, 655(2), 1994, pp. 286-292
Citations number
10
Categorie Soggetti
Chemistry Analytical
Journal title
Journal of chromatography B. Biomedical applications
ISSN journal
15726495 → ACNP
Volume
655
Issue
2
Year of publication
1994
Pages
286 - 292
Database
ISI
SICI code
Abstract
A method is described that combines chiral HPLC and off-line GC with m ass-selective detection for the quantitation of the enantiomers of nis oldipine [(+)-I] in human plasma. An isotope-labelled internal standar d [nine-fold deuterated (+/-)-I] is used throughout the assay. The lim it of quantification is 0.1 mu g/l for each enantiomer. Data on the pr ecision, accuracy and selectivity of the method are presented. Enantio selective analysis was performed in subjects receiving the racemic dru g in tablet form. In healthy volunteers the maximum concentration and the area under the curve of the pharmacologically more active (+)-enan tiomer were greater by 9-fold and 13-fold, respectively, compared to t hose of the (-)-enantiomer. In elderly hypertensive patients plasma co ncentrations of (+)-I were ca. five times as high as those of the (-)- enantiomer. Stereoselectivity was not affected by hepatic impairment. After intravenous administration of (+/-)-I there were no relevant dif ferences between the plasma concentrations of the enantiomers.