• 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
ZHOU Ping, LI Li, WU Lulu, GU Chenhao, TIAN Huimin, REN Xiaoming, ZHANG Haijun, WU Jiaquan. Determination of osimertinib mesylate by HPLC[J]. Journal of China Pharmaceutical University, 2017, 48(3): 322-327. DOI: 10.11665/j.issn.1000-5048.20170312
Citation: ZHOU Ping, LI Li, WU Lulu, GU Chenhao, TIAN Huimin, REN Xiaoming, ZHANG Haijun, WU Jiaquan. Determination of osimertinib mesylate by HPLC[J]. Journal of China Pharmaceutical University, 2017, 48(3): 322-327. DOI: 10.11665/j.issn.1000-5048.20170312
shu

Determination of osimertinib mesylate by HPLC

More Information
    Graphical Abstract
    • Abstract
  • To establish an HPLC method to determine osimertinib mesylate, Agilent ZORBAX Eclipse Plus C18 column(4. 6 mm × 250 mm, 5 μm)was used with a mobile phase consisting of methanol-buffer solution(20 mmol/L NaH2PO4, pH 3. 0 adjusted with 85% H3PO4)(50 ∶50)at the flow rate of 1. 0 mL/min. The detection wavelength was 210 nm, and the column temperature was kept at 35 ℃. The calibration curve was liner over the range from 50% to 150% of determination concentration(0. 201 1- 0. 603 2 mg/mL, r=0. 999 9). The limit of quantitation(LOQ)and limit of detection(LOD)were 0. 32 μg/mL and 0. 08 μg/mL, respectively. The contents of osimertinib mesylate in samples were 100. 1%, 99. 5% and 99. 7%. Good chromatographic separation of osimertinib mesylate and its related substances, including synthetic impurities and degradation products, were obtained. The established HPLC method is specific, accurate, simple and durable, and could be used for the determination of osimertinib mesylate.
    • FullText(HTML)
    • References (8)
  • [1]
    Cross DA,Ashton SE,Ghiorghiu S,et al.AZD9291,an irreversible EGFR TKI,overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer[J].Cancer Discov,2014,4(9):1046-1061.
    [2]
    Kobayashi S,Boggon TJ,Dayaram T,et al.EGFR mutation and resistance of non-small-cell lung cancer to gefitinib[J].N Engl J Med,2005,352(8):786-792.
    [3]
    Yang X,Liangan C.Advances in primary resistance to EGFR-TKI in patients with non-small cell lung cancer[J].Acad J Chin PLA Med Sch(解放军医学院学报),2013,34(4):418-420.
    [4]
    Jiang T,Zhou C.Clinical activity of the mutant-selective EGFR inhibitor AZD9291 in patients with EGFR inhibitor-resistant non-small cell lung cancer[J].Trans Lung Cancer Res,2014,3(6):370-372.
    [5]
    U.S.Food and Drug Administration.FDA approves new pill to treat certain patients with non-small cell lung cancer[EB/OL].https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm472525.htm.
    [6]
    Liu H,Lyu Y,Li Y,et al.A novel and efficient synthesis of anti-cancer agent,mereletinib[J].J Chem Res,2015,39(6):318-320.
    [7]
    Butterworth S,Finlay MR,Ward RA,et al.Preparation of 2-(2,4,5-substituted-anilino)pyrimidine derivatives as EGFR modulators useful for treating cancer:WO,2013/14448[P].2012-07-25[2013-01-31] .
    [8]
    Rood JJ,van Bussel MT,Schellens JH,et al.Liquid chromatography-tandem mass spectrometric assay for the T790M mutant EGFR inhibitor osimertinib(AZD9291)in human plasma[J].J Chromatogr B,2016,1031:80-85.
    • Related Articles

  • Related Articles

    [1]LI Long, GUO Wei, YU Xiuli, XIE Chunwen. Determination of the related substances in desloratadine by HPLC[J]. Journal of China Pharmaceutical University, 2019, 50(6): 707-712. DOI: 10.11665/j.issn.1000-5048.20190611
    [2]XUE Xiaonan, ZHANG Zhengjin, ZOU Qiang, YAN Chao. Determination of dabigatran etexilate mesylate and related substances by HPLC[J]. Journal of China Pharmaceutical University, 2017, 48(6): 711-714. DOI: 10.11665/j.issn.1000-5048.20170612
    [3]ZHAO Xun, SHAO Fangxian, YUAN Yaozuo, ZHANG Mei, TAN Li. Determination of the related substances of benzyl hydroxybenzoate by RP-HPLC[J]. Journal of China Pharmaceutical University, 2017, 48(3): 317-321. DOI: 10.11665/j.issn.1000-5048.20170311
    [4]LIU Chao, ZHONG Xing, XI Yanqiong, TANG Yinxia, JIANG Li, WANG Fujun, PU Tong, ZENG Su. Determination of the related substances of tenofovir by RP-HPLC[J]. Journal of China Pharmaceutical University, 2015, 46(1): 78-80. DOI: 10.11665/j.issn.1000-5048.20150110
    [5]REN Hancheng, JIANG Fan, FAN Qingming, YUAN Lei, QIAN Zhiying, ZHAO Hailong. Determination of the related substances of atorvastatin calcium and intermediate L1 by HPLC[J]. Journal of China Pharmaceutical University, 2014, 45(1): 70-75. DOI: 10.11665/j.issn.1000-5048.20140112
    [6]ZHAO Xun, YUAN Yaozuo, ZHANG Mei, TAN Li. Determination of pyrazinamide and its related substances by HPLC[J]. Journal of China Pharmaceutical University, 2013, 44(6): 536-539. DOI: 10.11665/j.issn.1000-5048.20130609
    [7]XU Ying, WU Qiong-zhu, KE Xue. Determination of moxifloxacin hydrochloride and its related substances by HPLC[J]. Journal of China Pharmaceutical University, 2012, 43(1): 46-50.
    [8]HAN Jia-yi, ZHANG Yun, WANG Xin-yue. RP-HPLC gradient elution analysis for the determination of pantoprazole soldium and its related substances[J]. Journal of China Pharmaceutical University, 2009, 40(6): 531-534.
    [9]ZHANG Jin-lin, YUAN Yao-zuo, QIAN Wen, ZHANG Mei. Determination of secnidazole and its related substances by HPLC[J]. Journal of China Pharmaceutical University, 2009, 40(6): 527-530.
    [10]Determination of Ganciclovir and Its Related Substances by HPLC[J]. Journal of China Pharmaceutical University, 2004, (2): 38-40.

Catalog

    Get Citation
    PDF
    XML
    Article views (2431) PDF downloads (3484) 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：292734

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return