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学科主题: 临床医学
题名:
Comparison of liquid chromatography-ultraviolet and chromatography-tandem mass spectrometry for the determination of indapamide in human whole blood and their applications in bioequivalence studies
作者: Zhao, Libo2; Gu, Shifen; Xu, Rong; Cui, Xiaoyu; Gan, Fangliang; Chen, Hui1
关键词: Bioassay ; CAS 26807-65-8 ; Diuretic ; Indapamide ; Tandem mass spectrometry
刊名: ARZNEIMITTEL-FORSCHUNG-DRUG RESEARCH
发表日期: 2010
卷: 60, 期:7, 页:432-439
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Chemistry, Medicinal ; Chemistry, Multidisciplinary ; Pharmacology & Pharmacy
研究领域[WOS]: Pharmacology & Pharmacy ; Chemistry
关键词[WOS]: SOLID-PHASE EXTRACTION ; HUMAN PLASMA ; HEALTHY-VOLUNTEERS ; MS METHOD ; LC-MS/MS ; URINE ; SERUM
英文摘要:

The aim of this study was to compare two methods which were based on liquid chromatography with ultraviolet detection (LC-UV) and liquid chromatography-tandem mass spectrometry (LC-MS/MS), respectively, to determine indapamide (CAS 26807-65-8) and to apply them to bioequivalence studies. The universal parameters, including selectivity, linearity, precision, and quantification limit, served as gold standard for the comparison of the two methods. As a result, the two methods were both very consistent and reliable. Furthermore, the LC-MS/MS method required only one-fifth the blood volume needed by the other method and was approximately 25 times more sensitive than the other method. The total run time of the LC-MS/MS method was 3.5 min per sample as opposed to 11 min for the other method. Forty healthy male Chinese volunteers were selected as subjects. One half were orally administrered 2.5 mg indapamide immediate release tablets while the other half were orally administered 1.5 mg indapamide sustained release coated tablets. The collected blood samples were determined with the two methods described above. The pharmacokinetic parameters were determined using a noncompartmental method. For the bioequivalence studies, the pharmacoldnetic parameters acquired here were in line with the literature and parameters met the criteria set by the State Food and Drug Administration of China (SFDA) for bioequivalence study, indicating that generic drugs are bioequivalent to branded drugs. The present study suggests that the two methods based on LC-UV and LC-MS/MS were suitable for bioavailability studies of in-dapamide with different pharmaceutical formulations. Consequently, it can be believed that the criterion that each individual expected concentration range would need a given bioassay with the requested sensitivity is not absolutely right. In practice, most of the time, the highest sensitivity allows to bioassay concentrations in a higher range.

语种: 英语
WOS记录号: WOS:000280493800004
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/67408
Appears in Collections:北京大学第二临床医学院_药剂科_期刊论文

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作者单位: 1.Huazhong Univ Sci & Technol, Tongji Med Coll, Inst Clin Pharmacol, Dept Pharmacol, Wuhan 430030, Hubei, Peoples R China
2.Peking Univ, Peoples Hosp, Dept Pharm, Beijing 100871, Peoples R China

Recommended Citation:
Zhao, Libo,Gu, Shifen,Xu, Rong,et al. Comparison of liquid chromatography-ultraviolet and chromatography-tandem mass spectrometry for the determination of indapamide in human whole blood and their applications in bioequivalence studies[J]. ARZNEIMITTEL-FORSCHUNG-DRUG RESEARCH,2010,60(7):432-439.
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