离子色谱法测定甲磺酸伊马替尼中甲磺酸

Determination of methanesulfonic acid in imatinib mesylate by ion chromatographic

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IonPacAS11-HC阴离子分析柱(250mm×4.0mm),柱温30℃,电导检测器,进样量10μL,淋洗液为10mmol/L氢氧化钾溶液,体积流量1mL/min,采集时间10min。结果甲磺酸在38.5～192.6μg/mL线性关系良好(r=0.9997),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 ofmethanesulfonic acid in imatinib mesylatc. Methods The analysis was performed on IonPac ASll-HC negative ion column （250 mm×4.0 mm） with l0 mmol/L potassium hydroxide solution as cluent by electrical conductivity detector. The flow rate was l mL/min, detection time was l0 min, and the column temperature was 30 ~C, and the injection volume was 10 I^L. Results The linear relationship of mcthanesulfonic 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.