RP-HPLC法同时测定小儿氨酚烷胺颗粒中对乙酰氨基酚、咖啡因和马来酸氯苯那敏的含量  

Simultaneous Determination of Paracetamol, Caffeine and Chlorphenamine Maleate in Pediatric Paracetamol and Amantadine Hydrochloride Granules by High Performance Liquid Chromatography

作　　者：于海波 陈辉 

机构地区：[1]徐州市食品药品监督检验中心,江苏徐州221000

出　　处：《黑龙江医药》2017年第6期1181-1184,共4页Heilongjiang Medicine journal

基　　金：徐州市科技计划项目(XF11C039)

摘　　要：目的:建立高效液相色谱法同时测定小儿氨酚烷胺颗粒中对乙酰氨基酚、咖啡因和马来酸氯苯那敏含量的分析方法。方法:色谱柱:Agilent SB-C_(18)柱(150mm×4.6mm,5μm);流动相:以甲醇为流动相A,以0.2%磷酸(含0.3%的三乙胺)为流动相B,梯度洗脱;流速:1.0ml·ml^(-1);检测波长为268 nm。结果:对乙酰氨基酚的线性范围为205.8~2058μg·ml^(-1)(r=0.9998);咖啡因的线性范围为12.06~120.6μg·ml^(-1)(r=0.9999);马来酸氯苯那敏的线性范围为1.611~16.11μg·ml^(-1)(r=0.9998),平均回收率(n=9)分别为98.45%、99.54%和98.55%,RSD分别为为0.72%、0.55%和0.65%。结论:该方法专属性好、操作简便、快速准确,可用于小儿氨酚烷胺颗粒的质量控制。Objective: To establish an HPLC method for the determination of paracetamol, caffeine and chlorphenamine maleate in pediatric paracetamol and amantadine hydrochloride granules. Methods: The column was Agilent SB-C_(18)(150 mm×4.6 mm, 5μm),the mobile phase was methanol and with gradient elution at a flow rate of 1.0 ml·ml^(-1). The detection wavelength was 268 nm. The column temperature was 30℃, and the injection volume was 20μl. Results: The standard curve of paracetamol was linear in the range of205.8~2058 μg·ml^(-1)(r=0.9998). The average recovery was 98.45% with RSD of 0.72%(n=9). The standard curve of caffeine was linear in the range of 12.06~120.6 μg·ml^(-1)(r=0.9999). The average recovery was 99.54% with RSD of 0.55%(n=9). The standard curve of chlorpheniramine maleate was linear in the range of 1.611~16.11 μg·ml^(-1)(r=0.9998). The average recovery was 98.55% with RSD of 0.65%(n=9). Conclusion: This method is simple with high accuracy and reproducibility, which can be used in the quality control of pediatric paracetamol and amantadine hydrochloride granules.

关 键 词：小儿氨酚烷胺颗粒 对乙酰氨基酚 咖啡因 马来酸氯苯那敏 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]