• 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
WANG Yingxin, LIU Ling, LI Shuying, LAN Yi, NIE Lei. Analysis of related substances in montelukast sodium granules by HPLC-MS/MS[J]. Journal of China Pharmaceutical University, 2019, 50(3): 330-336. DOI: 10.11665/j.issn.1000-5048.20190309
Citation: WANG Yingxin, LIU Ling, LI Shuying, LAN Yi, NIE Lei. Analysis of related substances in montelukast sodium granules by HPLC-MS/MS[J]. Journal of China Pharmaceutical University, 2019, 50(3): 330-336. DOI: 10.11665/j.issn.1000-5048.20190309
shu

Analysis of related substances in montelukast sodium granules by HPLC-MS/MS

More Information
    Graphical Abstract
    • Abstract
  • The aim of this paper was to study the species and sources of related substances in montelukast sodium granules based on HPLC-MS/MS. The related substances of the already marketed montelukast sodium granules(Singulair, 4 mg)were firstly separated and identified by HPLC-MS/MS method, and their chemical structures and sources were confirmed according to the pulished synthesis process and degradation studies. The results revealed that there were 7 related substances, whose chemical structures and sources were confirmed based on the MS/MS technique and the related literature. Impurity 7 , montelukast quinoline ring oxynitride, had not been reported. This study systematically analyzed the related substances in the commercical product, which provides useful information for the development and quality control of the product.
    • FullText(HTML)
    • References (9)
  • [1]
    Wang F. Application and clinical effectiveness of montelukast sodium in the treatment of asthma in children[J].J Chin Prescrip Drug(中国处方药),2017,15(3):76-77.
    [2]
    Zhao QH,Guo F.Clinical efficacy of montelukast sodium in the treatment of asthma in children[J].J Mod Diagn Treat(现代诊断与治疗),2017,28(18):3391-3392.
    [3]
    Yang J,Li J.Clinical study of montelukast sodium in the treatment of childhood asthma[J].J Pract Med Clin(实用药物与临床),2016,19(5):606-609.
    [4]
    European Pharmacopoeia Convention.European Pharmacopoeia 8.0[S].Strasbourg:European Directorate for the Quality of Medicines & HealthCare,2013:2794-2796.
    [5]
    The United States Pharmacopoeial Convention. United States Pharmacopoeia 40[S].Rockville:The United States Pharmacopeial Convention,2017:5220-5222.
    [6]
    Belley,Leger ML,Labelle S,et al.Unsaturated hydroxyalkylquinoline acids as leukotriene antagonists:US,5565473[P].1996-10-15[2019-02-15] .
    [7]
    Al Ommri MM.Effect of light and heat on the stability of montelukast in solution and in its solid state[J].J Pharm Biomed Anal,2007,45:465-471.
    [8]
    Down B.Granule Formation:US,8007830B2[P].2011-08-30[2019-02-15] .
    [9]
    Zhou LS,Qu HM.Progress in quinoline nitrogen oxide[J].J Chem Propel Poly Mater(化学推进剂与高分子材料),2000(3):9-11.
    • Related Articles

Catalog

    Get Citation
    PDF
    XML
    Article views (518) PDF downloads (1178) Cited by()
    Turn off MathJax
    Article Contents
    Abstract
    References

    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：285541

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return