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不同检测器-顶空气相色谱法测定甲磺酸达比加群酯中的甲磺酸乙酯和甲磺酸异丙酯 被引量:6

Comparison on Different Detectors for the Determination of Ethyl and Isopropyl Methanesulfonate in Dabigatran Etexilate Mesylate by Headspace Gas Chromatography
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摘要 建立了顶空气相色谱法(HS-GC)测定甲磺酸达比加群酯中的甲磺酸乙酯和甲磺酸异丙酯,对比研究了不同检测器,即氢火焰离子检测器(FID)、电子捕获检测器(ECD)和质谱检测器(MS),主要从灵敏度、空白干扰性和样品测定等方面进行详细比较与评价,以期为不同品种药物活性成分(APIs)中甲磺酸酯含量测定方法的建立提供参考。 Headspace GC methods with different detectors were established and compared for the determination of ethyl and isopropyl methanesulfonate in dabigatran etexilate mesylate, including FID, ECD and MS detectors. Detailed comparisons and evaluations were conducted mainly from the sensitivity, interference and sample determination, in order to provide a reference for the establishment of determination methods for methanesulfonates in different APIs.
出处 《中国医药工业杂志》 CAS CSCD 北大核心 2015年第10期1108-1112,共5页 Chinese Journal of Pharmaceuticals
关键词 甲磺酸达比加群酯 甲磺酸乙酯 甲磺酸异丙酯 顶空气相色谱 测定 dabigatran etexilate mesylate ethyl methanesulfonate isopropyl methanesulfonate headspace capillary gas chromatography determination
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参考文献12

  • 1Hauel N, Ries U, Priepke H, et al, Disubstituted bicycle heterocycles, their production and use as medicaments: WO, 9837075 [P]. 1998-02-16.
  • 2宫平,贾薇.新型口服抗凝血药物达比加群酯[J].世界临床药物,2008,29(9):544-547. 被引量:26
  • 3Jayaraman VR, Patel S, Mistry S, et al. An improved process for the preparation of dabigatran etexilate mesylate: WO, 2014020555 [P]. 2014-02-06.
  • 4Elder DP, Teasdale A, Lipczynski AM. Control and analysis of alkyl esters of alkyl and arylsulfonic acids in novel active pharmaceutical ingredients (APIs) [J]. J Pharm Biomed Anal, 2008, 46(1): 1-8.
  • 5Bolt HM, Foth H, Hengstler JG, et al. Carcinogenicity categorization of chemicals-new aspects to be considered in a European perspective [J]. Toxicol Lett, 2004,151 (1) : 29-41.
  • 6European Medicines Agency. CPMP/SWP/5199/02, EMEA/ CHMP/QMP/251344/2006. Evaluation of medicines for human use, guideline on the limit ofgenotoxic impurities [S]. 2006.
  • 7European Medicines Agency. EMEA/CHMP/SWP/ 431994/2007. Pre-authorisation evaluation of medicines for human use, question & answers on the CHMP guideline on the limits of genotoxic impurities [S]. 2008.
  • 8U.S. Department of Health and Human Services Food and Drug Administration. Guidance for industry: genotoxic and carcinogenic impurities in drug substances and products: recommended approaches (draft guideline) [S]. 2008.
  • 9张园园,李银峰,王杰晶,李佩,靳朝东.药物中痕量磺酸酯类物质的检测技术研究进展[J].药物评价研究,2012,35(4):304-307. 被引量:20
  • 10Lee CR, Guivarch F, van Dau CN, et al. Determination of polar alkylating agents as thiocyanate/isothiocyanate derivatives by reaction headspace gas chromatography [J]. Analyst, 2003, 128 (7) : 857-863.

二级参考文献25

  • 1全球医药快讯[J].世界临床药物,2009(12):578-579. 被引量:6
  • 2陈敖,黄荷香,宋帅娟,陈小琴.甲磺酸伊马替尼的合成[J].精细与专用化学品,2007,15(8):23-25. 被引量:11
  • 3李玉兰.极谱法测定尿液中甲磺酸伊马替尼的含量[J].药物分析杂质,2008,28 (6): 996-998.
  • 4Elder DP,Teasdale A,Lipczynski AM.Control and analysis of alkyl and arylBiomed Anal,2008,46 ( 1 ): 1-8.
  • 5Sitaram C, Rupakula RB.Determination of alkyl methanesulfonates indoxazosin mesylate by gas chromatography-mass spectrometeifj].Indian JPharm Sci,2011,73 ( 1 ): 107-110.
  • 6Stopper H, Lutz WK. Induction of micronuclei in human cell linesand primary cells hy combination treatment with 3-radiation and ethylmethanesulfonate[J].Mutagenesis, 2002,17 : 177-181.
  • 7Garolaa A, Rup6reza FJ,Ceppa F, et al. Development of chromatographicmethods for the determination of genotoxic impurities in cloperastinefendizoate[J].J Pharm Biomed Anal,2012,61 : 230-236.
  • 8European Medicines Agency.Evaluation of medicines for humanuse,guideline on the limits of genotoxic impurities [S].CPMP/SWP/5199/02,EMEA/CHMP/QWP/251344/2006 (2007 ).
  • 9Raman Nvvss,Prasad Avss,Reddy KR. Strategies for the identification,control and determination of genotoxic impurities in drug substance: Apharmaceutical industry perspective[J]J Pharm Biomed Anal, 2011,55(4): 662-667.
  • 10Stopper H,Lutz W K. Induction of micronuclei in human cell lines and primary cells by combination treatment with (I)3-radiation and ethyl methanesulfonate[J].Mutagenesis,2002.177-181.

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