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A high-performance liquid chromatographic method for the determination of nicardipine in plasma and its application to pharmacokinetics in humans

โœ Scribed by Ke Li; Xin Zhang; Yi-sheng Yuan; Fei-lang Zhao


Publisher
John Wiley and Sons
Year
1998
Tongue
English
Weight
55 KB
Volume
12
Category
Article
ISSN
0269-3879

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โœฆ Synopsis


A simple and sensitive reversed-phase liquid chromatographic method has been developed and validated for the analysis of nicardipine in human plasma and the study of the pharmacokinetics of the drug in human body. Nicardipine and nimodipine (internal standard) in plasma were extracted with hexane-butanol (12:1, v/v) after addition of borate buffer (0.5 mol/mL, pH = 9.0), and then measured by HPLC using a Hypersil C 18 column as stationary phase and acetonitrile -KH 2 PO 4 buffer (0.015 M, pH = 5.5) -triethylamine as mobile phase. Nicardipine was quantified by ultraviolet absorbance at 236 nm. The method proved to be linear in the clinical range of 5-200 ng/mL with a regression coefficient of 0.9998. The lower limit of detection of nicardipine in plasma was 2.5 ng/mL. Intra-and inter-day coefficients of variation of assay for nicardipine in plasma were 3.5-5.4% (n = 7) and 5.2-6.4% (n = 5), respectively. The recovery of nicardipine was 92.8-100.8% for plasma. The method has been used to determine nicardipine in plasma samples from 10 volunteers and provided data on the pharmacokinetics of the drug. The results inferred that nicardipine is absorbed rapidly and has a relatively short half-life in healthy individuals. The data obtained was fitted with a 3P87 program to study the pharmacokinetics. The results showed that the disposition of nicardipine was conformed to a two-compartment open model with T max = 1.6 AE 0.3 h, C max = 109.8 AE 38.7 ng/mL, T 1/2 = 5.35 AE 2.28 h and AUC 0โ†’? = 322.1 AE 69.6 ng/h/mI.


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