复方氨麻木酚口服液5种有效成分含量测定方法的建立  

Establishment of A Method for Content Determination of Five Active Ingredients in Compound Methylephedrine Oral Solution

作　　者：赵文[1] 毛睿[1] 陈华[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2014年第1期66-70,共5页Chinese Pharmaceutical Affairs

摘　　要：目的建立复方氨麻木酚口服液中5种有效成分(对乙酰氨基酚、咖啡因、愈创木酚磺酸钾、马来酸氯苯那敏、d,l-盐酸甲基麻黄碱)的含量测定方法。方法采用Agilent Eclipse XDB C18柱;对乙酰氨基酚、咖啡因、愈创木酚磺酸钾以乙腈-0.1%磷酸溶液(含7.2mM三乙胺及1%四氢呋喃)(10∶90)为流动相;马来酸氯苯那敏、d,l-盐酸甲基麻黄碱以乙腈-0.1%磷酸(含0.1%辛烷基磺酸钠)(27∶73)为流动相;上述5种成分的检测波长均为220nm;进样量为20μL;柱温为30℃。结果对乙酰氨基酚、咖啡因、愈创木酚磺酸钾、马来酸氯苯那敏、d,l-盐酸甲基麻黄碱分别在一定的浓度范围内与峰面积呈良好的线性关系(r分别为0.99996、0.99988、0.99987、0.99980、0.99992),加样回收率分别为99.9%、99.2%、98.0%、98.6%、101.0%。结论本法简便、快速,结果准确,重现性好,可作为该产品的含量测定方法。Objective To establish an assay method for the active pharmaceutic ingredients （APIs） of Compound Methylephedrine Oral Solution,including paracetamol,acetaminophen,caffeine,potassium guaiacol sulfonic acid,chlorpheniramine maleate and d,l-methyl-ephedrine hydrochloride.Methods The determination of 5 APIs was performed on the Agilent Eclipse XDB C18 column（4.6 mm×150 mm,5 μm）using 2 different solvent systems as mobile phases respectively： acetonitrile-0.1% phosphoric acid solution （containing 7.2 mM triethylamine and 1% tetrahydrofuran） （10：90） for determination of acetaminophen,caffeine and potassium guaiacol sulfonic acid,acetonitrile-phosphate 0.1% （including 0.1% essien alkyl sulfonate） （27：73） for chlorpheniramine maleate and d,l-methyl-ephedrine hydrochloride.The detection wavelength was 220 nm and the column temperature was 30 ℃.Results Excellent linear behaviors over the investigated concentration ranges were observed for acetaminophen,caffeine,potassium guaiacol sulfonic acid,chlorpheniramine maleate and d,l-methyl-ephedrine hydrochloride （r=0.99996,0.99988,0.99987,0.99980,0.99992）.And the recoveries were 99.9%,99.2%,98.0%,98.6% and 101.0%,respectively.Conclusion The method is accurate,rapid and reproducible for the determination of the five APIs in Compound Methylephedrine Oral Solution.

关 键 词：复方氨麻木酚口服溶液 对乙酰氨基酚 咖啡因 愈创木酚磺酸钾 马来酸氯苯那敏 d l-盐酸甲基麻黄碱高效液相色谱法 含量测定 

分 类 号：R917[医药卫生—药物分析学]