摘要
目的:建立高效液相色谱(HPLC)法测定氨酚麻美干混悬剂中对氨基酚杂质的含量,为氨酚麻美干混悬剂的质量控制提供科学依据。方法:采用Agilent Zorbax SB-C18(4.6 mm×250 mm,5μm)色谱柱,流动相为0.05 mol·L^(-1)醋酸铵溶液-甲醇(88∶12),流速为1.0 mL·min^(-1),柱温为30℃,检测波长为231 nm,溶剂为含10 mg·L^(-1)抗坏血酸的混合溶液。结果:对氨基酚在0.04806~4.806μg·mL^(-1)的浓度范围内与峰面积的线性关系良好,r=1.000(n=6);检测限为0.07 ng;平均回收率为98.4%,RSD为1.3%(n=9);供试液在24 h内稳定。结论:该方法简便、准确、灵敏、专属性好,可用于氨酚麻美干混悬剂中对氨基酚的含量测定。
Objective:To establish a HPLC method to determine the content of the relative substance of 4-aminophenol in paracetamol,pseadoephedrine hydrochloride and dextromethorphan hydrobromide for suspension,to provide scientific basis for quality control of paracetamol,pseadoephedrine hydrochloride and dextromethorphan hydrobromide for suspension.Methods:The Agilent Zorbax SB-C18(4.6 mm×250 mm,5μm)column was adopted with the mobile phase of 0.05 mol·L^(-1)ammonium acetate-methanol(88∶12)at the flow rate of 1.0 mL·min^(-1).The temperature of column was 30℃and the detection wavelength was 231 nm and a mixture containing 10 mg·L^(-1)ascorbic acid was used as solvent.Results:The linear relationship of 4-aminophenol was good in the range of 0.04806-4.806μg·mL^(-1),r=1.000(n=6).The limit of detection was 0.07 ng and the average recovery was 98.4%.The RSD was 1.3%(n=9).Test solutions were stable in 24 h and not required to prepare immediately before use.Conclusion:The method is simple,accurate,sensitive and with good specificity,which can be used for content determination of 4-aminophenol in this product.
作者
梁智渊
刘晶晶
刘敏
李玉兰
王铁杰
LIANG Zhiyuan;LIU Jingjing;LIU Min;LI Yulan;WANG Tiejie(Shenzhen Institute for Drug Control, Shenzhen Key Laboratory of Pharmaceutical Quality Standard Research,Guangdong Shenzhen 518057, China)
出处
《中国医药导刊》
2021年第7期514-517,共4页
Chinese Journal of Medicinal Guide
基金
2016年中央补助地方食品药品安全监管任务药品标准修订项目分配(项目编号:食药监办药化管【2016】141号-297,项目名称:氨酚麻美干混悬剂)。
关键词
氨酚麻美干混悬剂
高效液相色谱法
有关物质
对氨基酚
抗坏血酸
Paracetamol,pseadoephedrine hydrochloride and dextromethorphan hydrobromide for suspension
HPLC
Related substances
4-aminophenol
Ascorbic acid
