Determination of tegaserod in human plasma by liquid chromatography-  tandem mass spectrometry and its application to bioequivalence study

	Determination of tegaserod in human plasma by liquid chromatography- tandem mass spectrometry and its application to bioequivalence study
	WANG Yu 2; CHEN Xiaoyan2 ; DAI Xiaojian2 ; ZHONG Dafang2 ; ZHANG Yifan2 ; WEN Aidong 1
刊名	Chinese Journal New Drugs
	2007
卷号	16 期号:13 页码:1049-1053
关键词	tegaserod liquid chromatography-tandem mass spectrometry bioequivalence
ISSN号	1003-3734
其他题名	LC-MS／MS法测定人血浆中替加色罗的浓度及其在生物等效性研究中的应用
文献子类	Article
英文摘要	Objective: To develop and validate a liquid chromatographic-tandem mass spectrometric(LC-MS/MS)method for the determination of tegaserod in human plasma.Methods:Tegaserod and internal standard,diphenhydramine were isolated from plasma by liquid-liquid extraction.The chromatographic separation was achieved within 3 min on Zorbax XDB-C18 column(150 mm*4.6 mm,5 mum)with an isocratic mobile phase consisted of acetonitrile-5 mmol·L~(-1) ammonium acetate-formic acid(70∶30∶0.01)at the rate of 0.5 mL·min-1.Multiple reaction monitoring(MRM)transitions of 302173 and m/z256167 were measured in positive mode for tegaserod and the internal standard, respectively.Results:The linear concentration range of the calibration curve for tegaserod was 0.010~10 ng·mL~(-1).The lower limit of quantification was 0.010 ng·mL~(-1).The intra-and inter-day relative standard deviations(RSD)across three validation runs over the entire concentration range were less than 7.3%,the accuracies(RE)were within1.4%.After an oral dose of 6 mg,the pharmacokinetic parameters of tegaserod in test and reference tablets were as follows: Tmax(0.860.22)and(1.010.24)h,Cmax(2.210.69)and(2.050.64)ng·mL~(-1),t_(1/2)alpha(1.180.44)and(1.240.56)h,t1/2beta(10.103.07)and(8.812.35)h,AUC0~36 h(6.352.48)and(6.471.99)ng·h·mL-1,AUC0~(6.692.59)and(6.702.03)ng·h·mL~(-1),respectively.The relative bioavailability of tegaserod dispersible tablet was(98.222.1)%.Conclusion:The method was sensitive,rapid,accurate and suitable for bioequivalence study of tegaserod in human subjects.
WOS研究方向	Pharmacology & Pharmacy (provided by Clarivate Analytics)
语种	中文
CSCD记录号	CSCD:2957591
内容类型	期刊论文
源URL	[http://119.78.100.183/handle/2S10ELR8/268118]
专题	药物化学研究室
作者单位	1.Department of Pharmacy, X ijing Hospital, The Fourth Military Medical University, Xi＇an, Shaanxi 710032, China. 2.Center for Drug Metabolism and Pharmacokinetics Research, Shanghai Institute of Materia Medica Chinese Academy of Sciences, Shanghai 201203, China.;
推荐引用方式 GB/T 7714	WANG Yu,CHEN Xiaoyan,DAI Xiaojian,et al. Determination of tegaserod in human plasma by liquid chromatography- tandem mass spectrometry and its application to bioequivalence study[J]. Chinese Journal New Drugs,2007,16(13):1049-1053.
APA	WANG Yu,CHEN Xiaoyan,DAI Xiaojian,ZHONG Dafang,ZHANG Yifan,&WEN Aidong.(2007).Determination of tegaserod in human plasma by liquid chromatography- tandem mass spectrometry and its application to bioequivalence study.Chinese Journal New Drugs,16(13),1049-1053.
MLA	WANG Yu,et al."Determination of tegaserod in human plasma by liquid chromatography- tandem mass spectrometry and its application to bioequivalence study".Chinese Journal New Drugs 16.13(2007):1049-1053.