Nevirapine quantification in human plasma by high-performance liquid chromatography coupled to electrospray tandem mass spectrometry. Application to bioequivalence study

被引:18
|
作者
Laurito, TL
Santagada, V
Caliendo, G
Oliveira, CH
Barrientos-Astigarraga, RE
De Nucci, G
机构
[1] State Univ Campinas, Fac Med Sci, Campinas, SP, Brazil
[2] Univ Naples Federico II, Dipartamento Chim Farmaceut & Tossicol, I-80131 Naples, Italy
[3] Univ Sao Paulo, Inst Biomed Sci, Dept Pharmacol, Carteslus Analyt Unit, BR-05508900 Sao Paulo, Brazil
来源
JOURNAL OF MASS SPECTROMETRY | 2002年 / 37卷 / 04期
关键词
liquid chromatography/tandem mass spectrometry; high-performance liquid chromatography; dibenzepine; bioanalysis;
D O I
10.1002/jms.300
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
A rapid, sensitive and specific method to quantify nevirapine in human plasma using dibenzepine as the internal standard (IS) was developed and validated. The method employed a liquid-liquid extraction. The analyte and the IS were chromatographed on a C-18 analytical column, (150 x 4.6 mm i.d. 4 mum) and analyzed by tandem mass spectrometry in the multiple reaction monitoring mode. The method had a chromatographic run time of 5.0 min and a linear calibration curve over the range 10-5000 ng ml(-1) (r(2) > 0.9970). The between-run precision, based on the relative standard deviation for replicate quality controls was 1.3% (30 ng ml(-1)), 2.8% (300 ng ml(-1)) and 3.6% (3000 ng ml(-1)). The between-run accuracy was 4.0, 7.0 and 6.2% for the above-mentioned concentrations, respectively. This method was employed in a bioequivalence study of two nevirapine tablet formulations (Nevirapina from Far-Manguinhos, Brazil, as a test formulation, and Viramune from Boehringer Ingelheim do Brasil Quimica e Farmaceutica, as a reference formulation) in 25 healthy volunteers of both sexes who received a single 200 mg dose of each formulation. The study was conducted using an open, randomized, two-period crossover design with a 3 week washout interval. The 90% confidence interval (CI) of the individual ratio geometric mean for Nevirapina/Viramune was 96.4-104.5% for AUC((0-last)), 91.4-105.1% for AUC((0-infinity)) and 95.3-111.6% for C-max (AUC = area under the curve; C-max = peak plasma concentration). Since both 90% CI for AUC((0-last)) and AUC((0-infinity)) and C-max were included in the 80-125% interval proposed by the US Food and Drug Administration, Nevirapina was considered bioequivalent to Viramune according to both the rate and extent of absorption. Copyright (C) 2002 John Wiley Sons, Ltd.
引用
收藏
页码:434 / 441
页数:8
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