Determination of tegaserod in human plasma by liquid chromatography- tandem mass spectrometry and its application to bioequivalence study
文献类型：期刊论文
| 作者 | WANG Yu2; CHEN Xiaoyan2 ; DAI Xiaojian2; ZHONG Dafang2; ZHANG Yifan2; WEN Aidong1
|
| 刊名 | Chinese Journal New Drugs
 |
| 出版日期 | 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 |
| 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. |
入库方式： OAI收割
来源：上海药物研究所
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