【摘要】 目的 建立富马酸卢帕他定原料药有机溶剂残留量测定方法。方法 采用气相色谱法测定，色谱柱为DB-WAXETR毛细管柱(30m×0.32mm×0.25μm) ，检测器温度300℃，进样口温度200℃，柱温：35℃，保持10min，以每分钟20℃升温至220℃，保持2min；流速为1ml/min，载气为高纯氮气，分流比为5:1；溶剂为N-甲基吡咯烷酮。结果 待测物均能得到很好的分离，峰面积与浓度呈良好的线形关系，精密度良好。结论 该法可用于富马酸卢帕他定原料药中有机溶剂残留量的检测。

    【关键词】 富马酸卢帕他定；有机残余溶剂；GC

    Detection of organic residual solvents in rupatadine fumarate by GC

    YU Yong-fa，HUANG Yong.Institute of Pharmaceutical Research,Yangtze River Pharmacy Group Co.Ltd,Taizhou,225321,China

    【Abstract】 Objective To establish a method for detection of the residual solvents in rupatadine fumarate.Methods The residual solvents in rupatadine fumarate were determined by GC with DB-WAXETR capillary column(30m×0.32mm×0.25μm),FID detector and using nitrogen as carrier gas.The injector temperature was 200℃ and the detector temperature was 300℃,the column temperature was raised by program,the initial temperature was 35℃,maintained for 10min ,raised to 220℃ with a rate of nitrogen was 1ml/min,maintained for 2min,the flow rate of nitrogen was 2ml/min.The split ratio was 5:1.Results The solvents can be completely separated and the calibration curves of each solvent showed good linear relationgship within a certain range.Conclusion The method is accurate and reliable.It can be applied in detection of residual solvents in Rupatadine Fumarate. ......