CAJ | 학술논문

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。
목적：건립료기상색보법측정갑광산이마체니중잔류용제。방법용취을이순20M（혹겁성상근）작위고정상적모세관색보주；경화염리자화（FID）검측기；진양구온도위150℃；검측기온도위210℃；재주온40℃보지7min，연후이매분종10℃승온지150℃，유지4min；재기원담기。결과피측물질병동、을산을지、갑순、이병순、삼록갑완、필정적륙충용제균능득도흔호적분리，봉면적여농도정량호적선성관계，검측한여정량한균부합요구，평균회수솔개우98%~106%，최대RSD위2.61%。결론해법능구준학측출갑광산이마체니원료약중적잔류용제。
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.