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盐酸苯达莫司汀有关物质结构鉴定

陈文华, 邹丽敏, 张斐, 张连第, 廖明毅, 丁黎

陈文华, 邹丽敏, 张斐, 张连第, 廖明毅, 丁黎. 盐酸苯达莫司汀有关物质结构鉴定[J]. 中国药科大学学报, 2015, 46(3): 333-338. DOI: 10.11665/j.issn.1000-5048.20150312
引用本文: 陈文华, 邹丽敏, 张斐, 张连第, 廖明毅, 丁黎. 盐酸苯达莫司汀有关物质结构鉴定[J]. 中国药科大学学报, 2015, 46(3): 333-338. DOI: 10.11665/j.issn.1000-5048.20150312
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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
Citation: 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
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盐酸苯达莫司汀有关物质结构鉴定

  • 1.

    中国药科大学药物分析教研室

  • 2.

    江苏先声药业有限公司

Identification of the related substances in bendamustine hydrochloride

摘要

    摘要
  • 摘要: 建立HPLC法对盐酸苯达莫司汀的有关物质进行分析，检测出2个有关物质IMP01和 IMP02；通过LC-MS/MS法推测出2个有关物质的结构，并合成制备得到2个有关物质单体，根据Q-TOF/MS以及NMR结果综合解析确证了两个有关物质结构，IMP01为4-(1-甲基-5-吗啉-2-苯并咪唑基)丁酸盐酸盐，IMP02为4-{1-甲基-5-［(2-氯乙基)(2-羟乙基)氨基］-2-苯并咪唑基}丁酸盐酸盐。结果显示，在建立的LC-MS条件下，盐酸苯达莫司汀与其有关物质分离良好，通过分析鉴定有关物质结构，为其工艺和质量控制提供了参考依据。
    Abstract: In the HPLC analysis of bendamustine hydrochloride, two related substances(IMP01 and IMP02)were detected. These two related substances were identified by LC-MS/MS and their structural confirmation was unambiguously carried out by synthesis followed by characterization using Q-TOF/MS and NMR. Based on the spectral data, related substances IMP01 and IMP02 were characterized as 4-(1-methyl-5-morpholino-1H-benzo［d］imidazol-2-yl)butyric acid hydrochloride and 4-{1-methyl-5-［(2-chloroethyl)(2-hydroxyethyl)amino］-1H-benzo［d］imidazol-2-yl)} butyric acid hydrochloride, respectively. Bendamustine hydrochloride and its related substances were separated under the established LC-MS condition. HPLC is a useful method for the determination of the related substances in bendamustine hydrochloride. Results obtained are valuable for its manufacturing process and quality control.
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    • 参考文献(9)
  • [1] Cuneo A,Marchetti M,Barosi G,et al.Appropriate use of bendamustine in first-line therapy of chronic lymphocytic leukemia.Recommendations from SIE,SIES,GITMO Group[J].Leukemia Res,2014,38(11):1269-1277.
    [2] Höffken K,Merkle KH,Schönfelder M,et al.Bendamustine as salvage treatment in patients with advanced progressive breast cancer:a phase II study[J].J Cancer Res Clin,1998,124(11):627-632.
    [3] Elefante A, Czuczman MS. Bendamustine for the treatment of indolent non-Hodgkin′s lymphoma and chronic lymphocytic leukemia[J].Am J Health Syst Pharm,2010,67(9):713-723.
    [4] Pönisch W,Dietger N.Bendamustine in the treatment of multiple myeloma:results and future perspectives[J].Semin Oncol,2002,29(4):23-26.
    [5] Liu ZR,Ye XL,Fan GR,et al.Electrospray ionization tandem mass spectrometry analysis of bendamustine hydrochloride[J].Pharm Care Res(药学服务与研究),2012,12(6):414-417.
    [6] Liu ZR,Ye XL,Fan GR.Degradation compounds and their structural confirmation of bendamustine hydrochloride in process of clinical administration[J].Chin J New Drugs Clin Rem(中国新药与临床杂志),2013,32(3):211-216.
    [7] Mathrusri AM,Venkatesh B,Anusha S,et al.Stability-indicating liquid chromatographic method for the determination of bendamustine hydrochloride in parenterals[J].Res J Chem Sci,2012,2(9):72-78.
    [8] Tang H,Wu XM,Peng S.Determination of bendamustine hydrochloride and related substance by HPLC[J].Pharm Clin Res(药学与临床研究),2009,17(4):303-305.
    [9] Kasa S,Reddy MRS.Stability-indicating LC method for the estimation of bendamustine hydrochloride and its related impurities[J].J Chromatogr Sci,2014,52(7):573-583.
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  • 刊出日期:  2015-06-24

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