高效液相色谱法同时测定阿司匹林片中阿司匹林和水杨酸含量  

Simultaneous determination of aspirin and salicylic acid in aspirin tablets by high performance liquid chromatography

作　　者：赵勇 郑金凤 刘雁鸣 张悦 ZHAO Yong;ZHENG Jinfeng;LIU Yanming;ZHANG Yue(NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Hunan Institute for Drug Control,Hunan,Changsha 410006,China)

机构地区：[1]湖南省药品检验检测研究院国家药品监督管理局药用辅料工程技术研究重点实验室,湖南长沙410006

出　　处：《中国医药科学》2023年第17期78-81,共4页China Medicine And Pharmacy

摘　　要：目的 建立同时测定阿司匹林片中阿司匹林和水杨酸含量的方法。方法 采用高效液相色谱法(HPLC),C18柱(4.6 mm×250 mm,5μm),以磷酸-乙腈-水(2∶400∶600)为流动相;流速:1 ml/min,紫外检测波长:237 nm,进样量:10μl。结果 在该色谱条件下,阿司匹林片中阿司匹林、水杨酸及其各杂质能完全分离;阿司匹林在10~500μg/ml的浓度范围线性关系良好(r=0.9998);平均回收率为100.04%(RSD=0.54%);水杨酸在2~50μg/ml的浓度范围线性关系良好(r=0.9999);平均回收率为98.47%(RSD=0.97%)。结论 本方法准确度高、重现性好,可用于阿司匹林类药物含量和有关物质的测定。Objective To establish a method for the simultaneous determination of aspirin and salicylic acid in aspirin tablets.Methods High-performance liquid chromatography(HPLC)with C18 column(4.6 mm×250 mm,5μm)and phosphoric acid-acetonitrile-water(2∶400∶600)as the mobile phase was used.Flow rate:1 ml/min,UV detection wavelength:237 nm,injection volume:10μl.Results Under this chromatographic condition,aspirin,salicylic acid,and their impurities in aspirin tablets could be completely separated;Aspirin ranged from 10 to 500μg/ml with a good linear relationship(r=0.9998).The average recovery rate was 100.04%(RSD=0.54%).Salicylic acid ranged from 2 to 50μg/ml with a good linear relationship(r=0.9999).The average recovery rate was 98.47%(RSD=0.97%).Conclusion This method has high accuracy and good reproducibility and can be used for the determination of aspirin and related substances.

关 键 词：阿司匹林 水杨酸 高效液相 质量标准 

分 类 号：R927[医药卫生—药学]