衍生气相色谱法测定甲磺酸伊马替尼中甲磺酸烷基酯类

GC-FID-derivative technique determination of methanesulfonic acid alkyl ester in imatinib mesylate

目的建立衍生气相色谱法同时检测甲磺酸伊马替尼中的甲磺酸甲酯、甲磺酸乙酯、甲磺酸异丙酯三种甲磺酸烷基酯。方法采用NaI—H2O碘化衍生，利用ZB—WAX石英毛细管柱（30m×0．53mm，1．0μm）分离，氢火焰离子化（FID）检测器。结果方法在0．070～13．0μg／mL具有良好的线性（r〉0．999），检出限0．2ppm，回收率94．1％～111.3％。结论该方法可用于甲磺酸伊马替尼中甲磺酸甲酯、甲磺酸乙酯、甲磺酸异丙酯三种甲磺酸烷基酯成分的同时碘化衍生分离分析，方法简便，结果可靠、重现性好。

Objective To establish a derivative gas chromatography method simultaneously quantitative determination of methyl methanesulfonate（MMS）, ethyl methanesulfonate（EMS）, isopropyl methanesulfonate（IMS） in imatinib mesylate. Methods NaI-H2O solution as the iodonation agent, ZB-WAX （ 30m×0.53mm,1.0μm） capillary column was used to separate the fatty acids an d FID for quantitative decermination. Results Excellent linearity shelwed within the range of 0.070-13.0 μg/mL（r 〉 0.999）, detection limit was 0.2ppm, and the recovery rate was 94.1%-111.3%. Conclusion The method shows satisfactory repeatability, simplicity and convenience, and is valid in simultaneous derivation separation and analysis of these methanesulfonic acid alkyl ester in imatinib mesylate.