气相色谱法同时测定复方氨酚烷胺片中4种成分的含量
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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.
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.
引文
[1]国家食品药品监督管理局.复方氨酚烷胺片[S].WS1-XG-015-2002.2003.
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[3]田洪根,王洪明.HPLC法测定复方氨酚烷胺片中马来酸氯苯那敏的含量及含量均匀度[J].中国药品标准,2008,9(3):207-209.
[4]石强.HPLC法同时测定复方氨酚烷胺片中咖啡因、马来酸氯苯那敏的含量及含量均匀度[J].齐鲁药事,2012,31(10):585-587.
[5]王军,权勤波,宋建建,等.UFLC同时测定复方氨酚烷胺片中对乙酰氨基酚和咖啡因的含量[J].中国药师,2009,12(12):1775-1777.
[6]谢华,傅萍,张悦杨,等.HPLC测定复方氨酚烷胺片中的对乙酰氨基酚、咖啡因和马来酸氯苯那敏[J].华西药学杂志,2012,27(3):307-308.
[7]黄军.RP-HPLC法测定复方氨酚烷胺片中4种主要成分的含量[J].生命科学仪器,2006,4(6):16-18.
[8]黄义纯,刘旺培.HPLC测定氨咖黄敏中对乙酰氨基酚和咖啡因的含量[J].首都医药,2007,14(16):472-474.
[2]国家食品药品监督管理局.复方氨酚烷胺片[S].YBH06802005.2005.
[3]田洪根,王洪明.HPLC法测定复方氨酚烷胺片中马来酸氯苯那敏的含量及含量均匀度[J].中国药品标准,2008,9(3):207-209.
[4]石强.HPLC法同时测定复方氨酚烷胺片中咖啡因、马来酸氯苯那敏的含量及含量均匀度[J].齐鲁药事,2012,31(10):585-587.
[5]王军,权勤波,宋建建,等.UFLC同时测定复方氨酚烷胺片中对乙酰氨基酚和咖啡因的含量[J].中国药师,2009,12(12):1775-1777.
[6]谢华,傅萍,张悦杨,等.HPLC测定复方氨酚烷胺片中的对乙酰氨基酚、咖啡因和马来酸氯苯那敏[J].华西药学杂志,2012,27(3):307-308.
[7]黄军.RP-HPLC法测定复方氨酚烷胺片中4种主要成分的含量[J].生命科学仪器,2006,4(6):16-18.
[8]黄义纯,刘旺培.HPLC测定氨咖黄敏中对乙酰氨基酚和咖啡因的含量[J].首都医药,2007,14(16):472-474.