Determination of Didanosine in Human Plasma and Its Application to a Bioequivalence Study
文献类型：期刊论文
| 作者 | Jin Fengdan2; Chen Xiaoyan1 ; Yu Hezhou3; An Xiaoxia3; Zhong Dafang1
|
| 刊名 | Chinese Pharmaceutical Journal
 |
| 出版日期 | 2006 |
| 卷号 | 41期号:13页码:1016-1019 |
| 关键词 | didanosine liquid chromatography-tandem mass spectrometry bioequivalence |
| ISSN号 | 1001-2494 |
| 其他题名 | 血浆中去羟肌苷测定与制剂生物等效性评价 |
| 文献子类 | Article |
| 英文摘要 | OBJECTIVE To develop a sensitive and specific LC-MS/MS method for the determination of didanosine in human plasma and to study the bioequivalence of different formulations containing didanosine. METHODS After a simple protein precipitation using acetonitrile, the samples were analyzed by liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters of didanosine in two formulations were calculated by non-compartment analysis. RESULTS The linear calibration curves were obtained in the concentration range of 5.0 - 2 000 mug·L^-1. The intm- and inter-day relative standard deviations （RSD） over the entire concentration range were less than 6%. Accuracy （RE） determined at three concentrations was within 4%. Pharmacokinetic parameters for the reference formulation were obtained as follows： tmax was （0.650.30） h, rhomax= was （1 052353） mug·L^-1, t1/2 was （1.530.38） h, AUC0-t, was （1 628479） pg·h·L^-1 Pharmacokinetic parameters for the lest formulation were obtained as follows： tmax was （0.47 0.13） h, rhomax was （ 1 090 531 ） mug·L^-1, t1/2 was （ 1.44 0.46） h , AUC0-t was （ 1 520 661 ） mug·h·L^-1 .The relative bioavailability of the test formulation to the reference was （95.8 20.8） %. CONCLUSION The method is sensitive, rapid, robust, and is proved to be suitable for bioequivalence evaluation of formulations containing didanosine. |
| WOS研究方向 | Pharmacology & Pharmacy (provided by Clarivate Analytics) |
| 语种 | 中文 |
| CSCD记录号 | CSCD:2552974 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/268201]  |
| 专题 | 上海药物代谢研究中心 |
| 通讯作者 | Zhong Dafang |
| 作者单位 | 1.Shangha/Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.; 2.Laboratory of Drug Metabolism and Phannacokinetics, Shenyang Pharmaceutical University, Sbenyang, 110016.; 3.Northeast General Pharmaceuical Factory, Shenyang, Liaoning 110026, China. |
| 推荐引用方式 GB/T 7714 | Jin Fengdan,Chen Xiaoyan,Yu Hezhou,et al. Determination of Didanosine in Human Plasma and Its Application to a Bioequivalence Study[J]. Chinese Pharmaceutical Journal,2006,41(13):1016-1019. |
| APA | Jin Fengdan,Chen Xiaoyan,Yu Hezhou,An Xiaoxia,&Zhong Dafang.(2006).Determination of Didanosine in Human Plasma and Its Application to a Bioequivalence Study.Chinese Pharmaceutical Journal,41(13),1016-1019. |
| MLA | Jin Fengdan,et al."Determination of Didanosine in Human Plasma and Its Application to a Bioequivalence Study".Chinese Pharmaceutical Journal 41.13(2006):1016-1019. |
入库方式： OAI收割
来源：上海药物研究所
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