于文萃,高毓涛
YU Wencui,GAO Yutao

• 1:辽宁地质工程职业学院
• 2:丹东市药品检验检测中心

摘要(Abstract)：

目的建立同时测定复方氨酚那敏颗粒中对乙酰氨基酚、咖啡因和马来酸氯苯那敏含量的高效液相色谱(HPLC)法。方法采用Waters Sun Fire C18色谱柱(4.6 mm×150 mm,5μm),流动相为磷酸盐缓冲液-甲醇(75∶25,V/V),柱温为25℃,进样量为20μL,流速为1.0 m L·min~(-1),检测波长为210 nm。结果对乙酰氨基酚的线性范围为100.4~802.9μg·m L~(-1)(r=0.999 7),平均回收率为99.5%(RSD=0.9%,n=6),咖啡因的线性范围为9.974~79.79μg·m L~(-1)(r=0.999 4),平均回收率为99.3%(RSD=1.5%,n=6),马来酸氯苯那敏的线性范围为1.042~8.336μg·m L~(-1)(r=0.999 9),平均回收率为99.9%(RSD=1.4%,n=6)。结论本法简便,快速,准确,重现性好,适用于复方氨酚那敏颗粒的质量控制。
OBJECTIVE To establish an HPLC method for determination of paracetamol,caffeine and chlorphenamine maleate in compound paracetamol and chlorphenamine maleate granules simultaneously. METHODS Waters Sun Fire C18( 4.6 mm×150 mm,5μm) at 25 ℃ was used with phosphate buffer and methanol( 75 ∶25,V/V) as the mobile phase,the flow rate was 1.0 m L·min~(-1) and detection wavelenth was set at 210 nm. RESULTS The calibration curves for paracetamol,caffeine and chlorphenamine maleate were linear over the range of 100.4-802.9 μg·m L~(-1)( r= 0.999 7),9.974-79.79 μg·m L~(-1)( r= 0.999 4) and 1.042-8.336 μg·m L~(-1)( r= 0.999 9),respectively. The average recovery rates were 99.5%( RSD = 0.9%,n = 6),99.3%( RSD = 1.5%,n = 6) and 99.9%( RSD = 1.4%,n = 6),respectively. CONCLUSION This method is simple,rapid,accurate and reliable,which is suitable for the quality control of compound paracetamol and chlorphenamine maleate granules.

关键词(KeyWords)： 复方氨酚那敏颗粒;含量测定;高效液相色谱
compound paracetamol and chlorphenamine maleate granules;content determination;HPLC

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 于文萃,高毓涛
YU Wencui,GAO Yutao

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