HPLC法同时测定酚氨咖敏片中四种主药成分的含量  

Simultaneous Determination of Four Main Components in Paracetamol,Aminophenazone,Caffeine and Chlorphenamine Maleate Tablets by HPLC

作　　者：苏思尹 孔凡建 王晓瑶 

机构地区：[1]玉溪食品药品检验所,云南玉溪653100

出　　处：《中国药品标准》2017年第6期443-448,共6页Drug Standards of China

摘　　要：目的:建立HPLC法同时测定酚氨咖敏片中氨基比林、对乙酰氨基酚、咖啡因、马来酸氯苯那敏四种有效成分含量的方法。方法:采用Agilent ZORBAX SB C_(18)柱(4.6 mm×250 mm,5μm),流动相为磷酸二氢钠-乙睛(80∶20)(用磷酸调p H值至2.5),流速为1.0 mL·min^(-1),,检测波长为280 nm,柱温为40℃,进样量为20μL。结果:对乙酰氨基酚、氨基比林、咖啡因、马来酸氯苯那敏平均回收率(n=9)分别为99.76%、100.40%、99.46%、99.67%;RSD分别为0.9%、0.8%、0.7%、0.4%。对乙酰氨基酚在12.23~195.80μg·mL^(-1),氨基比林在20.40~163.20μg·mL^(-1),咖啡因在6.09~97.44μg·mL^(-1),马来酸氯苯那敏在5.20~83.26μg·mL^(-1)浓度范围内呈良好线性关系。按拟定的方法,分别对不同厂家3个批次的样品进行含量测定,计算标示含量,对乙酰氨基酚的标示含量分别为:94.2%、101.6%、99.3%;氨基比林的标示含量分别为:100.3%、95.6%、98.9%;咖啡因的标示含量分别为:98.5%、93.8%、100.4%;马来酸氯苯那敏标示含量分别为:90.1%、91.2%、104.5%。结论:本方法操作简便,结果准确可靠,可用于酚氨咖敏片中对乙酰氨基酚、氨基比林、咖啡因、马来酸氯苯那敏的含量测定。Objective：To establish an HPLC method for the simultaneously determining the contents of paracetamol , aminophenazone , caffeine ,chlorphenamine maleate in tablets. Methods：The HPLC gradient elution method was adopted with the Agilent ZORBAX SB-C18 column （4.6mm ×250mm,5μm）as the chromatographic column , sodium dihydrterogen phosphate – acetonitrile（80：20）（adjusting pH to 2.5 with phosphoric acid）as the mobile phase , the flow rate of 1.0mL·min-1, the detection wavelength was 280nm and the column temperature was 40℃,the injection volume were 20μl. Result ： The average recoveries （n=9） of paracetamol、aminophenazone、caffeine、chlorhenamine were 99.76%、100.40%、99.46 %、99.67% ; and the RSD were 0.9%、0.8%、0.7%、0.4%.The linear ranges of four components were at 12.23～195.80μg·mL- 1,20.40～163.20μg·mL- 1,6.09～97.44μg·mL- 1,5.20～83.26μg·mL- 1.According to the method , determination of four main components assay form the content of different batchs of the three manufacturers.The paracetamol were 94.2%、101.6%、99.3%; the aminophenazon were 100.3%、95.6%、98.9% ; the caffeine were 98.5%、93.8%、100.4%;the chlorpheniramine were 90.1%、91.2%、104.5%. Conclusion：This method is accurate, reliable and simple. It can be applied to simultaneous determination of four main components assay in paracetamol , aminophenazone , caffeine and chlorhenamine tablets.

关 键 词：高效液相色谱法 酚氨咖敏片 对乙酰氨基酚 氨基比林 咖啡因 马来酸氯苯那敏 含量测定 

分 类 号：R921.2[医药卫生—药学]