气相色谱法同时测定帕洛诺司琼中的8种有机溶剂残留量

目的]测定帕洛诺司琼中甲醇、甲苯、乙酸乙酯、乙醇、四氢呋哺、丙酮、异丙醇、正己烷的含量。方法]采用毛细管气相色谱法，色谱系统：HP-5色谱柱、程序升温、载气为氮气、检测器为FID，外标法计算含量。结果]在选定的色谱条件下，测得各有机溶剂的线性良好（r〉0．99）；平均回收率96．35％～103．67％，RSD1．37％～3．04％，最低检出限0．27～0．38ng，3批样品中8种有机溶剂残留量均符合要求。结论]经方法学试验验证，该方法灵敏、准确、可靠，适用于本品有机溶剂残留量的测定。

Determination of Residual Organic Solvents in Palonosetron by Capillary Gas Chromatography

Objective]To determine the contents of the residual methanol, toluene, ethyl acetate, acetone, ethanol, tetrahydrofuran,isopropylalcohol,and n-hexane in palonosetron. Methods]A simple capillary gas chromatography method was established with FID detector. The capillary column was HP-5 with programed temperature rsing. The residues were calculated by an external standard method.Results]The linearity of all the eight residual solvents was fairly good. The average recoveries were 96, 35%-103.67% with RSD of 1.37%-3.04%. The limit of detection was 0.27-0.38 ng. The contents of the eight residual organic solvents in three hatches of samples all reached the standard requirements. Conclusion] The method was proved to be accurate, sensitive and reliable. It is suitable for the test analysis of the eight kinds of solvents.