Determination of concentration of nisoldipine in human plasma by HPLC-MS method and investigation of its pharmacokinetics / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics
;
(12)2004.
Article
in Chinese
| WPRIM
| ID: wpr-555425
ABSTRACT
AIM:
To determine the concentration of nisoldipine in human plasma by HPLC-MS method and investigate the pharmacokinetics of sustained and immediate-release preparations.METHODS:
A C 18 column was used to separate nisoldipine from plasma with the mobile phase of a mixture of methanol-water-acetic acid (7525 0.1) at a flow rate of 1.0 ml?min -1. MS atmospheric pressure electronic spray ionization (AP-ESI) and ion mass spectral (m/z) of 411 were selected to quantify nisoldipine. Internal standard (IS) atmospheric pressure electronic spray ionization and m/z of 441 for nimodipine.RESULTS:
The linear range of the standard curve of nisoldipine was 0.2- 50 ?g?L -1 and the determination limit was 0.15 ?g?L -1. The recovery rate was more than 70%, and intra-day relative standard deviation (RSD) and inter-day RSD were less than 10%. After being given a single dose of 10 mg nisoldipine sustained release tablet, sustained release capsule and normal tablet, the half life(t 1/2 /h) were 6.08? 1.48, 7.06? 1.80 and 3.70? 0.25, the time to peak concentration (T peak /h) were 5.4? 0.7, 5.8? 0.4 and 2.0? 0.2, the peak concentration (C max / ?g?L -1) were 3.43? 0.55, 3.71? 0.24 and 9.18? 3.78, the area under time- concentration curve (AUC 0-t / ?g?h -1?L -1) were 31.10? 5.00, 33.63? 7.16 and 32.72? 5.09. But after being given multiple doses of nisoldipine, C max/ ?g?L -1 were 5.20? 0.27, 3.91? 0.22 and 5.30? 1.04, C min / ?g?L -1 were 0.72? 0.10, 0.77? 0.07 and 0.53? 0.07, DF were 175.00%? 16.34%, 177.10%? 18.43% and 247.92%? 57.71% respectively. The bioavailability of sustained- release tablet and capsule were 96%?12% and 102%?9% respectively.CONCLUSION:
The determination of concentration of nisoldipine in human plasma by HPLC-MS method is sensitive and accurate. It can be used for the investigation of the bioavailability and pharmacokinetic of nisoldipine.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
Chinese Journal of Clinical Pharmacology and Therapeutics
Year:
2004
Type:
Article
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