毛细管GC法测定扑尔敏霜中马来酸氯苯那敏的含量

目的:建立测定扑尔敏霜中马来酸氯苯那敏含量的方法。方法:采用毛细管气相色谱法。毛细管柱为HP-5石英柱,进样口温度为270℃,经程序升温,初始温度为95℃;检测器为氢火焰离子化检测器(FID),检测器温度为300℃;载气为氮气,流速为25mL·min-1,进样量为1.0μL。结果:马来酸氯苯那敏检测浓度在0.2～2.0mg·mL-1范围内与对照品峰面积积分和内标峰面积积分的比值呈良好线性关系(r=0.9996);平均加样回收率为98.5%,RSD=0.5%(n=6)。结论:该方法简便快速、结果准确,可用于扑尔敏霜的质量控制。

Content Determination of Chlorphenamine Maleate in Chlorphenamine Cream by Capillary GC

OBJECTIVE：To establish a method for the content determination of chlorphenamine maleate in Chlorphenamine cream.METHODS：Capillary GC method was adopted.The determination was performed on HP-5 silicon capillary column,and injector temperature was 270 ℃.The column temperature was raised by programming with initial temperature at 95 ℃;the temperature of FID detector was 300 ℃;the carrier gas was nitrogen,and flow rate was set at 25 mL·min-1;the injector volume was 1.0 μL.The internal standard was diphenhydramine.RESULTS：The linear range of chlorphenamine was 0.2～2.0 mg·mL-1（r=0.999 6） with an average recovery of 98.5%（RSD=0.5%,n=6）.CONCLUSION：The method is simple,rapid and accurate,and it is suitable for the quality control of the drug.