Validation and application of a high-performance liquid chromatography/tandem mass spectrometry assay for sumatriptan in human plasma

被引:22
作者
Boulton, DW [1 ]
Duncan, GF [1 ]
Vachharajani, NN [1 ]
机构
[1] Bristol Myers Squibb Pharmaceut Res Inst, Clin Discovery, Princeton, NJ 08543 USA
关键词
3-[2-(dimethylamine)ethyl]-N-methyl-1H-indole-5-methanesulfonaminde; 5-hydroxytryptamine type 1B and 1D receptors; serotonin; nasal spray formulation; intranasal does; pharmacokinetic study;
D O I
10.1002/bmc.211
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
A sensitive and convenient high-performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS) assay is described for the (5-HTIB/ID) receptor agonist sumatriptan in human plasma. Sumatriptan was recovered from plasma (81.8 +/- 6.8%) by liquid-liquid extraction. The mobile phase flow rate was 0.3 m.L/min and consisted of methanol:water:formic acid (90:10:0.1, v/v/v). The analytical column (4.6 x 100mm) was packed with Partisil C-8 (5 mum). The standard curve was linear from 0.7 to 70.4 ng/mL (r(2) > 0.99). The lower limit of quantitation was 0.7 ng/mL. The assay was specific, accurate (percentage deviation from nominal concentrations were < 15%), precise and reproducible (within- and between-day coefficients of variation < 10.3%). Sumatriptan in plasma was stable over three freeze/thaw cycles and at room temperature for one day. The utility of the assay was demonstrated by following sumatriptan plasma concentrations in two healthy subjects for 8-12 h following a single 20 mg intranasal dose. Copyright (C) 2003 John Wiley Sons, Ltd.
引用
收藏
页码:48 / 52
页数:5
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