GC法测定达沙替尼中有机溶剂残留量

摘要

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 mL/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, withRSDs 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.