HPLC测定复方北豆根氨酚那敏片的含量及含量均匀度  

Determination of content and content uniformity of compound asiatic moonseed,paracetamol and chlophenamine maleate tablets by HPLC

作　　者：储忠英 

机构地区：[1]上海市松江食品药品检验所,上海201600

出　　处：《药物分析杂志》2014年第6期1134-1137,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的： 建立HPLC法测定复方北豆根氨酚那敏片中对乙酰氨基酚、咖啡因、马来酸氯苯那敏、绿原酸含量，并对其中咖啡因和马来酸氯苯那敏进行含量均匀度的检测。 方法： 采用C18（50 mm×4.6 mm，2.7 μm）色谱柱，流动相为甲醇-0.1%磷酸（15：85），流速0.8 mL·min^-1，检测波长262 nm（对乙酰氨基酚、咖啡因、马来酸氯苯那敏）、327 nm（绿原酸），柱温35 ℃。 结果： 对乙酰氨基酚、咖啡因、马来酸氯苯那敏、绿原酸浓度分别在5.964-238.6、7.192-287.7、1.434-57.34、2.522-15.13 μg·mL^-1范围内呈现良好的线性关系，平均回收率（n=9）均不低于99%。 结论： 本文建立的方法可同时测定多种成分且符合方法验证要求，可为复方北豆根氨酚那敏片质量控制提供一定的参考。Objective： To establish the HPLC method for determination of the content of acetaminophen,caffeine,chlorphenamine maleate,chlorogenic acid in compound asiatic moonseed,paracetamol and chlophenamine maleate tablets and carry out the content uniformity test for caffeine and chlorphenamine maleate. Methods： The HPLC method was performed on a Agilent C18 column （50 mm×4.6 mm,2.7 μm）.The mobile phase was methanol-0.1% phosphate acid （15： 85） at a flow rate of 0.8 mL·min^-1.The wavelength was 262 nm for acetaminophen,caffeine,chlorphenamine maleate and 327 nm for chlorogenic acid,and the temperature of column was 35 ℃. Results： The calibration curves were liner in the ranges of 5.964-238.6 μg·mL^-1,7.192-287.7 μg·mL^-1,1.434-57.34 μg·mL^-1,2.522-15.13 μg·mL^-1 for the four components.The average recoveries（n=9） were no less than 99% respectively. Conclusion： The method established in this paper can simultaneously determine a variety of ingredients and accords with the requirements of methods validation,which can provide reference for quality control of compound asiatic moonseed,paracetamol and chlophenamine maleate tablets.

关 键 词：高效液相色谱 复方北豆根氨酚那敏片 对乙酰氨基酚 咖啡因 马来酸氯苯那敏 绿原酸 含量 含量均匀度 

分 类 号：R917[医药卫生—药物分析学]