| 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: |
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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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