摘要
目的：建立了一种离子色谱法测定伊马替尼中二甲胺的方法。方法采用阳离子交换柱（Dionex IonPac CS12A 4mm×250mm），以20mmol/L甲磺酸溶液为流动相，流速为1.0mL/min，电导检测，柱温为30℃，检测器温度为35℃。结果检测限、定量限分别为0.0015μg/mL、0.0049μg/mL，在0.10～9.84μg/mL范围线性关系良好，相关系数r=1.0000（n=6），重复性试验的RSD为小于0.11%（n=6），回收率为97.5%， RSD为1.8%。结论本方法测定简单、准确、重现性好，可用于测定甲磺酸伊马替尼中二甲胺的残留。
Objective To establish a method the determination of dimethylamine in imatinib mesylate by ion chromatography. Methods The determination was carried out on a Dionex IonPac CS12A（250mm×4.6mm）column with 20mmol/L methanesulfonic acid solution as eluent by electrical conductivity detector.The flow rate was 1.0mL/min,The column temperature was 30℃,and temperature of conductivity detection pool was 35℃. Results There was a good linearity over the range of 0.10-9.84μg/mL with a the correlation coefficient r higher than 1.0000（n=6）.The RSD for repeatition was 0.11%（n=6）,The average recovery was 97.5%with RSD of accuracy at 1.8%. Conclusion The Methods was simple,accurate and good reproducibility,which can be used for the determination of dimethylamine for imatinib mesylate.
出处
《中国医药科学》
2015年第3期57-59,共3页
China Medicine And Pharmacy
关键词
离子色谱
二甲胺
甲磺酸伊马替尼
Imatinib mesylate
Dimethylamine
Ion chrmatography
