GC法测定达沙替尼中有机溶剂残留量

Determination of Residual Organic Solvents in Dasatinib by Capillary GC

目的建立毛细管气相色谱法(GC)测定达沙替尼中10种有机溶剂的残留量。方法色谱柱:DB-624;载气:氮气;流速:3.0 m L/min;柱温:程序升温;检测器:FID。结果各溶剂(乙醇、丙酮、异丙醇、正己烷、乙酸乙酯、四氢呋喃、二氧六环、吡啶、二甲基甲酰胺、二甲基亚砜)的平均回收率分别为98.4%,100.5%,101.7%,101.6%,99.3%,97.9%,101.8%,97.7%,98.2%和96.3%,RSD均小于2.0%。结论此法简便、准确、重复性好,可为达沙替尼的质量控制提供依据。

Objective To establish a capillary GC method for the determination of ten residual organic solvents in dasatinib. Methods A DB-624 column was adopted with temperature programming. The carry gas was nitrogen with flow rate of 3.0 mL/min. The detector was FID. Results The average recoveries of ethanol, acetone, isopropanol, n-hexane, ethyl acetate, tetrahydrofuran, dioxane, pyridine, dimethyl formamide and dimethyl sulfoxide were 98.4 %, 100.5 %, 101.7 %, 101.6 %, 99.3 %, 97.9 %, 101.8 %, 97.7 %, 98.2 % and 96.3 %, respectively, with RSDs less than 2.0 %. Conclusion The method is simple and accurate, with a good repeatability. It can be used for the quality control of dasatinib.