• 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
LIU Chaoyi, ZHANG Ge, HANG Taijun, WANG Lei, ZHANG Xiaofei, SONG Min. Identification of related substances in rivaroxaban by LC-MS[J]. Journal of China Pharmaceutical University, 2015, 46(4): 450-457. DOI: 10.11665/j.issn.1000-5048.20150411
Citation: LIU Chaoyi, ZHANG Ge, HANG Taijun, WANG Lei, ZHANG Xiaofei, SONG Min. Identification of related substances in rivaroxaban by LC-MS[J]. Journal of China Pharmaceutical University, 2015, 46(4): 450-457. DOI: 10.11665/j.issn.1000-5048.20150411
shu

Identification of related substances in rivaroxaban by LC-MS

More Information
    Graphical Abstract
    • Abstract
  • An LC-MS method was established for the identification of the related substances in rivaroxaban. HPLC separation was carried out on an Inert Sustain C18 column(250 mm×4. 6 mm, 5 μm)with linear gradient elution using a mobile phase consisting of 0. 2% formic acid acetonitrile and 0. 2% formic acid aqueous solution. Rivaroxaban and its related substances could be completely separated under the established HPLC conditions. The structures of the related substances were identified by electrospray positive ESI high resolution TOF/MS and MS/MS spectra determination and elucidation, and further verified through reference substances. Fifteen related substances were detected and identified to be three related substances of starting materials, four synthetic by-products and ten degradation products. The established method is useful for the identification of the related substances in rivaroxaban. The results obtained are valuable for its manufacturing control and quality assurance.
    • FullText(HTML)
    • References (13)
  • [1]
    Samama MM. The mechanism of action of rivaroxaban-an oral,direct factor Xa inhibitor-compared with other anticoagulants[J].Thromb Res,2011,127(6):497-504.
    [2]
    Terry C,Sum L.Rivaroxaban:an oral direct factor Xa inhibitor for the prevention of thromboembolism[J].Cardiol Rev,2009,17(4):192-197.
    [3]
    Thomas TF,Ganetsky V,Spinler SA.Rivaroxaban:an oral factor Xa inhibitor[J].Clin Ther,2013,35(1):4-27.
    [4]
    Çelebier M,Reçber T,Koçak E,et al.RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms[J].Braz J Pharm Sci,2013,49(2):359-366.
    [5]
    Kasad PA. Photolytic-thermal degradation study and method development of rivaroxaban by RP-HPLC[J].Int J Pharm Tech Res,2013,5(3):1254-1263.
    [6]
    Rohde G.Determination of rivaroxabana novel,oral,direct factor Xa inhibitor—in human plasma by high-performance liquid chromatography-tandem mass spectrometry[J].J Chromatogr B,2008,872(1/2):43-50.
    [7]
    Korostelev M,Bihan K,Ferreol L,et al.Simultaneous determination of rivaroxaban and dabigatran levels in human plasma by high-performance liquid chromatography-tandem mass spectrometry[J].J Pharm Biomed Anal,2014,100:230-235.
    [8]
    Ramisetti NR,Kuntamukkala R.Development and validation of a stability indicating LC-PDA-MS/MS method for separation,identification and characterization of process related and stress degradation products of rivaroxaban[J].RSC Adv,2014,4(44):23155-23167.
    [9]
    Xu J,Hu WH,Gu DF,et al.Identification and determination of related substances in atropine sulfate with hyphenated technique[J].J China Pharm Univ(中国药科大学学报),2014,45(4):438-443.
    [10]
    Jin C,Wang M,Na Q,et al.Identification of chromatographic-mass spectrometric structures of related substances in terazosin hydrochloride[J].Chin J Pharm Anal(药物分析杂志),2014,34(11):107-117.
    [11]
    Yuan J,Huang CJ,Zhang JW,et al.Synthesis of rivaroxaban[J].Chin J New Drugs(中国新药杂志),2010,19(23):2185-2187.
    [12]
    Gao Y,Liang B,Ni GW,et al.Graphical synthetic routes of rivaroxaban[J].Chin J New Drugs(中国新药杂志),2012,21(4):371-374.
    [13]
    Cai ZY,Wen YL,Zhang SL,et al.Preparation and structural confirmation of the related substances of rivaroxaban[J].Chin J Pharm(中国医药工业杂志),2014,45(4):303-307.
    • 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 (2075) PDF downloads (2075) 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