通迪胶囊中马兜铃酸Ⅰ测定方法的研究  

Study on Determination Method of Aristolochic AcidⅠin Tongdi Capsules

作　　者：梁晟 杨青 李瑞莲 Liang Sheng;Yang Qing;Li Ruilian(Hunan Institute for Drug Control,Hunan Pharmaceutical Excipients Testing and Inspection Center,Hunan Engineering&Technology Research Center for Pharmaceutical Quality Evaluation,Changsha 410001,China)

机构地区：[1]湖南省药品检验研究院,湖南药用辅料检验检测中心,湖南省药品质量评价工程技术研究中心,长沙410001

出　　处：《中国药事》2021年第7期751-756,共6页Chinese Pharmaceutical Affairs

基　　金：湖南省自然科学基金-科药联合基金项目(编号2020JJ9032)。

摘　　要：目的:建立通迪胶囊中马兜铃酸Ⅰ限量的UPLC测定方法。方法:样品用70%甲醇提取,提取液通过Phenomenex Strata-X-AW(60 mg·3 m L^(-1))小柱除杂后用UPLC法进行测定。结果:马兜铃酸Ⅰ在0.1494.957μg·m L^(-1)范围内线性关系良好(r^(2)=0.9994),平均回收率为92.80%,RSD=2.21%(n=6),7批样品中马兜铃酸Ⅰ的含量为4.568.94μg·g^(-1)。结论:本法灵敏、快速、准确、专属性强,可用于通迪胶囊中马兜铃酸Ⅰ的限量检查。Objective:To establish a UPLC method for the determination of Aristolochic AcidⅠin Tongdi Capsules.Methods:Samples were extracted with 70%methanol and detected by UPLC after removing impurities from Phenomenex Strata-X-AW (60 mg·3m L^(-1)) column.Results:The linearity range of Aristolochic AcidⅠwas from 0.149 to 4.957μg·m L^(-1) (r^(2)=0.9994).The average recovery of Aristolochic AcidⅠwas 92.80%with the RSD=2.21%(n=6).The concentrations of Aristolochic AcidⅠin 7 batches of samples were 4.56-8.94μg·g^(-1).Conclusion:The method is sensitive,rapid,accurate and specific enough to be used for the limited determination of Aristolochic AcidⅠin Tongdi Capsules.

关 键 词：通迪胶囊 马兜铃酸Ⅰ 超高效液相色谱 固相萃取 柱净化 限量检查 梯度洗脱 液质联用 

分 类 号：R917[医药卫生—药物分析学] R99[医药卫生—药学]