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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1 μL。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、2.515~80.48 μg/mL(r均为0.999 9);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 ℃, carrier gas was nitrogen gas, the flow rate is 1.5 mL/min, the split ratio was 20 ∶ 1 and injection volume was 1 μL. RESULTS: The linear range was 156.0-4 990.4 μg/mL for paracetamol, 125.7-4 023.2 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=0.999 9); 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%; 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.
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
Compound paracetamol and amantadine hydrochloride tabletGCParacetamolAmantadine hydrochlorideCaffeineChlorphenamine maleateContent
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