吉非罗齐中残留溶媒丙酮的测定

The Acetone Detection as Residual Solvents of Gemifibrozil

目的建立一种气相色谱法测定原料药吉非罗齐中丙酮有机溶剂残留量的方法。选正丙醇作内标物,以 N,N 二甲基甲酰胺为溶剂在极性弹性石英毛细柱上进行各组分分离,效果良好。(采用程序升温)柱温100℃保留2分钟,以20℃/min 的速率升180℃保留5分钟。进样口温度200℃,检测器温度250℃,分流比70:1。载气:高纯氮气流速:2.0ml/min 结果平均回收率丙酮105.1％结论该方法克服了进样量不准确的缺点,重现性好,精度高。

We detected the acetone content of Gemifibrozil using gas chromatography(GC) method.We used propam—l—ol as internal standard substance.The internal standard substance and the sample tested were dissolved in N,N—dimethylformamide.The Chromatographic condi- tion are carried out as following:the flexibility quartzose capillary column,temperature of the col- umn 100 C maintaining 2minutes and 20 C/min increased temperature rate to 180 C Maintaining 5 minutes,the temperature of the injection port 200℃,the temperature of the detector 250℃,the diffluent ratio 70:1 ,the carrier gas nitrogen and the flow rate 2.0ml/min.The result showed the average recovery rate of acetone is 105.1% and the preeinsion is better.