目的 建立离子色谱法测定甲磺酸伊马替尼中甲磺酸的检测方法。方法 采用IonPac AS11-HC阴离子分析柱（250 mm×4.0 mm），柱温30 ℃，电导检测器，进样量10 μL，淋洗液为10 mmol/L氢氧化钾溶液，体积流量1 mL/min，采集时间10 min。结果 甲磺酸在38.5～192.6 μg/mL线性关系良好（r = 0.999 7），准确度的RSD为0.23%。结论 本法准确、可靠，可作为甲磺酸伊马替尼中甲磺酸的测定方法。

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.

国家重大新药创制专项（2011ZX09401-097）