文章摘要
苏思尹,孔凡建,王晓瑶.HPLC法同时测定酚氨咖敏片中四种主药成分的含量[J].中国药品标准,2017,18(6):443-448
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 , Aminophena-zone , Caffeine,and Chlorhenamme Maleate Tablets by HPLC
投稿时间:2017-08-07  修订日期:2017-12-11
DOI:
中文关键词: 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
英文关键词: HPLC  Paracetamol  Aminophenazone  Caffeine  Chlorhenamme  Detemination of content.
基金项目:
作者单位E-mail
苏思尹 云南省玉溪市食品药品检验所 51097652@qq.com 
孔凡建 云南省玉溪市食品药品检验所  
王晓瑶 云南省玉溪市食品药品检验所  
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中文摘要:
      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 C18柱(4.6 mm×250 mm,5μm),流动相为磷酸二氢钠-乙睛(80:20)(用磷酸调pH值至2.5),流速为1.0mL·min-1, ,检测波长为280nm,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。
英文摘要:
      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.
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