• 中国精品科技期刊
  • 中国高校百佳科技期刊
  • 中国中文核心期刊
  • 中国科学引文数据库核心期刊
Advanced Search
SONG Lin, WANG Mao, WEN Aidong, YANG Lin, JIA Yuntao, XIE Huiru, JIANG Xuehua, WANG Ling. Determination of agomelatine in human plasma by LC-MS/MS:application to a pharmacokinetic study in Chinese volunteers[J]. Journal of China Pharmaceutical University, 2014, 45(6): 698-702. DOI: 10.11665/j.issn.1000-5048.20140615
Citation: SONG Lin, WANG Mao, WEN Aidong, YANG Lin, JIA Yuntao, XIE Huiru, JIANG Xuehua, WANG Ling. Determination of agomelatine in human plasma by LC-MS/MS:application to a pharmacokinetic study in Chinese volunteers[J]. Journal of China Pharmaceutical University, 2014, 45(6): 698-702. DOI: 10.11665/j.issn.1000-5048.20140615
shu

Determination of agomelatine in human plasma by LC-MS/MS:application to a pharmacokinetic study in Chinese volunteers

More Information
    Graphical Abstract
    • Abstract
  • To establish an LC-MS/MS method for the determination of agomelatine in human plasma and to study the pharmacokinetics in Chinese healthy volunteers following oral administration of agomelatine tablets. 72 volunteers were administered with single oral dose of 25 mg of agomelatine. The plasma concentration of agomelatine was determined by LC-MS/MS. The pharmacokinetic parameters were calculated by Phoenix WinNonlin 6. 3. 0. The calibration curve of agomelatine was linear over the range of 0. 051 3-10. 38 ng/mL(r=0. 999 4). The lower limit of quantification of agomelatine was 0. 051 3 ng/mL. Both intra- and inter-day RSD were less than 15%. The main pharmacokinetic parameters were as follows: cmax was(13. 25±15. 78)ng/mL; tmax was(0. 68±0. 41)h; AUClast was(14. 00±19. 26)ng/mL ·h; AUCinf was(14. 14±19. 35)ng/mL ·h and t1/2 was(0. 78±0. 44)h. The LC/MS/MS method was convenient, precise and reproducible. It can be used for the determination of agomelatine in human plasma and its clinical pharmacokinetic studies.
    • FullText(HTML)
    • References (10)
  • [1]
    Wang X, Ma HM, Zhou YS. The graphical synthetic routes of agomelatine[J].Chin J Med Chem(中国药物化学杂志),2012,99(4):334-336.
    [2]
    Landolt HP,Wehrle R.Antagonism of serotonergic 5-HT2A/2C receptors:mutual improvement of sleep,cognition and mood[J].Eur J Neurosci,2009,29(9):1 795-1 809.
    [3]
    Howland RH.Critical appraisal and update on the clinical utility of agomelatine,a melatonergic agonist,for the treatment of major depressive disease in adults[J].Neuropsychiatr Dis Treat,2009,5:563-576.
    [4]
    Millan M,Gobert A,Lejeune F,et al.The novel melatonin agonist agomelatine(S20098)is an antagonist at 5-hydroxytryptamine 2C receptors,blockade of which enhances the activity of frontocortical dopaminergic and adrenergic pathways[J].J Pharmacol Exp Ther,2003,306(3):954-964.
    [5]
    Banasr M,Soumier A,Hery M,et al.Agomelatine,a new antidepressant,induces regional changes in hippocampal neurogenesis[J].Biol Psychiatry,2006,59(11):1 087-1 096.
    [6]
    Wei MJ,Zhang ZF,Zhang ZF.Discussion on accuracy in the analysis of biological samples and improvement measures[EB/OL].(2012-04-11)[2012-09-30] .http://www.cde.org.cn/dzkw.do?method=largePage&id=312642.
    [7]
    European Medicines Agency. CHMP ASSESSMENT REPORT FOR Valdoxan[EB/OL].(2008-11-20)[2011-12-12] .http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000915/WC500046226.pdf.
    [8]
    European Medicines Agency.Guideline on the investigation of bioequivalence[EB/OL].(2010-01-20)[2011-12-12] .http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf.
    [9]
    Chow SC,Liu J.Design and Analysis of Bioavailability and Bioequivalence Studies[M].CRC Press,2000.
    [10]
    Patil SR,Nerurkar KK,Kalamkar AM,et al.Validated LC-MS/MS method for quantification of agomelatine in human plasma and its application in a pharmacokinetic study[J].J Mass Spectrom,2012,47(1):23-28.
    • Related Articles

  • Related Articles

    [1]ZHU Song, JIANG Jing, LIU Yang, ZOU Wenyu, HU Pengwei, LU Yuting, SONG Min, HANG Taijun. Structural identification of the related substances of lorazepam tablets by LC-MS[J]. Journal of China Pharmaceutical University, 2021, 52(5): 555-565. DOI: 10.11665/j.issn.1000-5048.20210507
    [2]LIANG Fangmei, NI Yueling, WANG Lu, HANG Taijun, SONG Min. Structural identification of the related substances of fusidic acid by LC-MS[J]. Journal of China Pharmaceutical University, 2018, 49(3): 322-332. DOI: 10.11665/j.issn.1000-5048.20180311
    [3]YIN Xiaoya, WANG Cheng, MING Guojun, HANG Taijun. Identification of the related substances in pioglitazone hydrochloride by hyphenated LC-MS techniques[J]. Journal of China Pharmaceutical University, 2017, 48(6): 701-710. DOI: 10.11665/j.issn.1000-5048.20170611
    [4]FANG Daqing, LIU Fang, ZHANG Sijia, CAI Chaoqun, LIU Minzhuo, LIU Jinghan, YANG Chunhua, WANG Hao. One new diterpenoid alkaloid from Aconitum carmichaeli[J]. Journal of China Pharmaceutical University, 2017, 48(5): 568-571. DOI: 10.11665/j.issn.1000-5048.20170510
    [5]CHEN Wenhua, ZOU Limin, ZHANG Fei, ZHANG Liandi, LIAO Mingyi, DING Li. Identification of the related substances in bendamustine hydrochloride[J]. Journal of China Pharmaceutical University, 2015, 46(3): 333-338. DOI: 10.11665/j.issn.1000-5048.20150312
    [6]ZHOU Yongmei, SHI Xianming, MA Lei, ZHANG Sifang. Isolation and identification of Withaphysalins from Physalis minima[J]. Journal of China Pharmaceutical University, 2015, 46(1): 62-65. DOI: 10.11665/j.issn.1000-5048.20150107
    [7]RAO Ya-kun, DING Li, YU Yong. Structural identification of two major impurities in sodium levofolinate[J]. Journal of China Pharmaceutical University, 2012, 43(4): 350-354.
    [8]WANG Ying, YIN Hong-ping, CHEN Tao, WANG Min. Preliminary structural identification and protection on renal cell injury of acidic polysaccharide from Cordyceps sinensis[J]. Journal of China Pharmaceutical University, 2009, 40(6): 559-564.
    [9]Isolation and Identification of Two Taxane DiterpenoidCompounds[J]. Journal of China Pharmaceutical University, 2001, (3): 32-34.
    [10]Studies on 1H NMR of Naturally Occurring Taxane Diterpenoids and Revising Suggestions on Some Structures[J]. Journal of China Pharmaceutical University, 1998, (4): 19-22+25.

Catalog

    Get Citation
    PDF
    XML
    Article views (1403) PDF downloads (1258) Cited by()
    Turn off MathJax
    Article Contents
    Abstract
    References
    Related Articles

    Copyright © Journal of China Pharmaceutical University苏ICP备12050101号-2

    Address：24 Tongjia Lane, Nanjing City, Jiangsu Province （210009）Tel: 025-83271566E-mail: xuebao@cpu.edu.cn

    Supported by: Beijing Renhe Information Technology Co., Ltd.  Baidu Analytics

    Total visits：295154

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return