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 mL/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156.0~4990.4、125.7~4023.2、19.14~612.4、2.515~80.48μg/mL(r均为0.9999);定量限分别为1.4、0.5、1.1、0.9 ng,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 ℃,car-rier gas was nitrogen gas,the flow rate is 1.5 mL/min,the split ratio was 20:1 and injection volume was 1μL. RESULTS:The lin-ear range was 156.0-4990.4 μg/mL for paracetamol,125.7-4023.2 μg/mL for amantadine hydrochloride,19.14-612.4 μg/mL for caffeine and 2.515-80.48 μg/mL for chlorphenamine maleate(all r=0.9999);the limits of quantification were 1.4,0.5,1.1,0.9 ng,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%;re-coveries 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 reli-able,and suitable for the simultaneous determination of paracetamol,amantadine hydrochloride,caffeine,chlorphenamine maleate in Compound paracetamol and amantadine hydrochloride tablet.
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