气相色谱法同时测定复方氨酚烷胺片中4种成分的含量  

Simultaneous Determination of 4 Components in Compound Paracetamol and Amantadine Hydrochloride Tablet by GC

作　　者：董秋香[1] 张月寒[1] 付萍萍[1] 刘志玮[1] 

机构地区：[1]保定市食品药品检验所,河北保定071051

出　　处：《中国药房》2017年第6期844-847,共4页China Pharmacy

摘　　要：目的:建立同时测定复方氨酚烷胺片中对乙酰氨基酚、盐酸金刚烷胺、咖啡因、马来酸氯苯那敏含量的方法。方法:采用气相色谱法。色谱柱为HP-5石英毛细管柱,程序升温,检测器为氢火焰离子化检测器,检测器温度为300℃,载气为氮气,流速为1.5 m L/min,分流比为20∶1,进样量为1μL。结果:对乙酰氨基酚、盐酸金刚烷胺、咖啡因、马来酸氯苯那敏检测质量浓度线性范围分别为156.0~4 990.4、125.7~4 023.2、19.14~612.4、2.515~80.48μg/m L(r均为0.999 9);定量限分别为1.4、0.5、1.1、0.9ng,检测限分别为0.4、0.2、0.3、0.3 ng;精密度、稳定性、重复性试验的RSD<2.0%;加样回收率分别为99.59%~101.77%(RSD=0.8%,n=9)、99.56%~101.80%(RSD=0.7%,n=9)、98.44%~100.83%(RSD=0.7%,n=9)、100.05%~101.91%(RSD=0.6%,n=9)。结论:该方法简便快速、准确可靠,适用于复方氨酚烷胺片中对乙酰氨基酚、盐酸金刚烷胺、咖啡因、马来酸氯苯那敏的同时测定。OBJECTIVE：To establish a method for the simultaneous determination of paracetamol,amantadine hydrochloride,caffeine,chlorphenamine maleate in Compound paracetamol and amantadine hydrochloride tablet. METHODS：GC was performed on the column of HP-5 sillica capillary,temperature programmed,detector was FID detector,with the temperature of 300 ℃,carrier gas was nitrogen gas,the flow rate is 1.5 m L/min,the split ratio was 20 ∶ 1 and injection volume was 1 μL. RESULTS：The linear range was 156.0-4 990.4 μ g/m L for paracetamol,125.7-4 023.2 μ g/m L for amantadine hydrochloride,19.14-612.4 μ g/m L for caffeine and 2.515-80.48 μg/m L for chlorphenamine maleate（all r=0.999 9）;the limits of quantification were 1.4,0.5,1.1,0.9ng,limits of detection were 0.4,0.2,0.3,0.3 ng;RSDs of precision,stability and reproducibility tests were lower than 2.0%;recoveries were 99.59%-101.77%（RSD=0.8%,n=9）,99.56%-101.80%（RSD=0.7%,n=9）,98.44%-100.83%（RSD=0.7%,n=9）and 100.05%-101.91%（RSD=0.6%,n=9）,respectively. CONCLUSIONS：This method is simple,rapid,accurate and reliable,and suitable for the simultaneous determination of paracetamol,amantadine hydrochloride,caffeine,chlorphenamine maleate in Compound paracetamol and amantadine hydrochloride tablet.

关 键 词：复方氨酚烷胺片 气相色谱法 对乙酰氨基酚 盐酸金刚烷胺 咖啡因 马来酸氯苯那敏 含量 

分 类 号：R917[医药卫生—药物分析学]