[关键词]
[摘要]
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。
[Key word]
[Abstract]
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.
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[基金项目]
国家重大新药创制专项(2011ZX09401-097)