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目的:建立了气相色谱法测定甲磺酸伊马替尼中残留溶剂。方法用聚乙二醇20M(或极性相近)作为固定相的毛细管色谱柱;氢火焰离子化(FID)检测器;进样口温度为150℃;检测器温度为210℃;在柱温40℃保持7min,然后以每分钟10℃升温至150℃,维持4min;载气院氮气。结果被测物质丙酮、乙酸乙酯、甲醇、异丙醇、三氯甲烷、吡啶的六种溶剂均能得到很好的分离,峰面积与浓度呈良好的线性关系,检测限与定量限均符合要求,平均回收率介于98%~106%,最大RSD为2.61%。结论该法能够准确测出甲磺酸伊马替尼原料药中的残留溶剂。“,”Objective Establish Gas Chromatography to test the residual solvents in Imatinib Mesylate.Methods Capil ary column with stationary phase PEG 20M (or similar polarity);FID detector;the inlet temperature is 150℃;the detector temperature is 210℃;keep for 7 min at column temperature 40℃,then rise temperature to 150℃with rate of 10℃per min,keep for 4 min;car ier gas:nitrogen.Results Al six solvents of acetone,ethyl acetate,methanol,isopropanol,chloroform and pyridine are wel separated,the peak area shows good linear relationship with the concentration,both limit of detection and limit of quantitation meet the requirements,the average recovery is between 98%and 106%,the maximum RSD is 2.61%.Conclusion This method can accurately test the residual solvents in Imatinib Mesylate.