摘要
目的建立毛细管顶空气相色谱法测定阿加曲班中的9种有机溶剂:甲醇、乙醇、乙腈、异丙醇、二氯甲烷、正己烷、乙酸乙酯、四氢呋喃、吡啶的残留量。方法色谱柱DB-624;载气为氮气,柱流速为3.0 mL/min;柱温为程序升温;检测器FID。结果各溶剂的平均回收率分别为99.0%,103.1%,102.9%,105.0%,103.2%,101.8%,97.7%,98.2%和97.1%,RSD小于2.0%。结论此法简便、准确、重复性好,为阿加曲班的质量控制提供了依据。
Objective To establish a headspace capillary GC method for the determination of nine residual organic solvents in argatroban, including methanol, ethanol, acetonitrile, isopropanol, dichloromethane, n-hexane, ethyl acetate, tetrahydrofuran and pyridine. Methods A DB-624 column was used with temperature programming. The carrier gas was nitrogen with 3.0mL/min flow rate. The detector was FID. Results The average recoveries were 99.0 %, 103.1%, 102.9 %, 105.0 %, 103.2 %, 101.8 %, 97.7 %, 98.2 % and 97.1% for methanol, ethanol, acetonitrile, isopropanol, dichloromethane, n-hexane, ethyl acetate, tetrahydrofuran and pyridine, respectively, with RSDs less than 2.0 %. Conclusion The method can be simple, accurate and repeatable, and can be used for the quality control of argatroban.
出处
《食品与药品》
CAS
2014年第4期282-284,共3页
Food and Drug
