摘要
目的建立左卡尼汀原料药中丙酮、乙醇等有机溶剂残留量的测定方法。方法采用顶空气相色谱法测定。色谱柱为HP-INNOWAX石英毛细管柱;进样口温度120℃;柱温50℃;氢火焰离子化检测器(FID),检测器温度260℃;载气为氮气;流量1.7 ml.min-1,分流比为2∶1;进样体积1 ml;顶空瓶平衡温度70℃,平衡时间60 min;以水为溶剂。结果丙酮、乙醇在4 min内分离良好,平均回收率分别为99.9%、99.2%,相对标准偏差分别为1.4%、1.8%(n=5)。结论该方法简单、快速、准确,可用于左卡尼汀原料药中有机溶剂残留量的检测。
AIM To establish a method for the determination of residual organic solvents in Levocarnitine. METHOD Residual organic solvents in Levocamitine were determined by Headspace GC with HP-INNOWAX capillary column, FID detector and using nitrogen as carrier gas. The injection temperature was 120℃, the column temperature was 50℃ and the detector temperature was 260℃. The flow rate of nitrogen was 1.7 ml·min^-1, The split ratio was 2： 1. The injection volume was 1 ml. The optimized equilibrium temperature was 70 ℃ and the equilibrium time was 60 rain. The solvent was water. RESULTS The acetone and alcohol were separated perfectly in 4 rain. The average recoveries were 99.9% and 99.2%,and RSD were 1.4%,1.8%（n=5） respetively. CONCLUSION The method is simple,rapid and accurate for the determination of residual organic solvents in Levocamitine.
出处
《江苏药学与临床研究》
2006年第5期309-311,共3页
Jiangsu Pharmacertical and Clinical Research
