目的 建立離子色譜法測(cè)定甲磺酸伊馬替尼中甲磺酸的檢測(cè)方法。方法 采用IonPac AS11-HC陰離子分析柱（250 mm×4.0 mm），柱溫30 ℃，電導(dǎo)檢測(cè)器，進(jìn)樣量10 μL，淋洗液為10 mmol/L氫氧化鉀溶液，體積流量1 mL/min，采集時(shí)間10 min。結(jié)果 甲磺酸在38.5～192.6 μg/mL線性關(guān)系良好（r = 0.999 7），準(zhǔn)確度的RSD為0.23%。結(jié)論 本法準(zhǔn)確、可靠，可作為甲磺酸伊馬替尼中甲磺酸的測(cè)定方法。

Objective To establish an ion chromatographic method for the determination of methanesulfonic acid in imatinib mesylate. Methods The analysis was performed on IonPac AS11-HC negative ion column (250 mm×4.0 mm) with 10 mmol/L potassium hydroxide solution as eluent by electrical conductivity detector. The flow rate was 1 mL/min, detection time was 10 min, and the column temperature was 30 ℃, and the injection volume was 10 μL. Results The linear relationship of methanesulfonic acid was 0.038 5— 0.192 6 mg/mL (r = 0.9997) with RSD of accuracy at 0.23%. Conclusion The method is accurate and reliable, which could be used for the determination of methanesulfonic acid in imatinib mesylate.

國(guó)家重大新藥創(chuàng)制專(zhuān)項(xiàng)（2011ZX09401-097）