甲磺酸伊马替尼中致突变杂质研究

张 兰平, 姚 彤, 刘 梦婷
连云港杰瑞药业有限公司

摘要

参照ICHM7（R1）制定了甲磺酸伊马替尼中致突变杂质甲磺酸甲酯（MMS）、甲磺酸乙酯(EMS)和甲磺酸异丙酯(IMS)的控制策略，研究确定采用GC-MS方法对其进行检测，采用6%氰丙基苯基和94%二甲基聚硅氧烷为固定相的毛细管柱，进样口温度为240℃；流速为每分钟1.5mL；进样量为1μL；分流比为20:1；载气为氮气；检测器为质谱，离子源为EI，MMS选择离子为79/80/95，EMS和IMS选择离子为79/97/109/123，线性关系、准确度等指标良好，符合ICHQ2（R1）要求。

关键词

致突变性杂质；甲磺酸甲酯（MMS）；甲磺酸乙酯（EMS）；甲磺酸异丙酯（IMS）；GC-MS

参考

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[2]TheInternationalCouncilforHarmonisationofTechnicalRequirementsforPharmaceuticalsforHumanUse(ICH).Val-idationofAnalyticalProcedures:Textandmethodology[EB/OL].[2020-05-15].https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf.

[3]CarcinogenicPotencyDatabase[EB/OL].[2020-05-15].https://files.toxplanet.com/cpdb/chempages/METHYL%20METHANESUL-FONATE.html.

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