HPLC-ELSD法测定肾康宁颗粒中黄芪甲苷含量  

Determination of Astragaloside Ⅳ in Shenkangning Granules by HPLC-ELSD

作　　者：龙白坚 夏国汉 黄东 吴良发 LONG Baijian;XIA Guohan;HUANG Dong;WU Liangfa(Jiangxi Institute for Drug Control Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《药品评价》2021年第19期1176-1178,共3页Drug Evaluation

摘　　要：目的:建立肾康宁颗粒中黄芪甲苷的含量测定方法。方法:采用HPLC-ELSD法,色谱柱为Diamonsil C18(4.6 mm×250 mm,5μm);流动相为乙腈-水(35∶65);流速1.0 mL/min;柱温30℃;漂移管温度105℃;气体流速2.5 L/min。结果:黄芪甲苷在0.404~12.12μg范围内呈良好的对数线性关系(r=0.9999),平均回收率(n=6)为95.5%。结论:该定量方法准确可靠,重现性好,可用于肾康宁颗粒的质量控制和监管。Objective:To establish a method for determination of astragaloside Ⅳ in Shenkangning granules.Methods:By using HPLC-ELSD,the analytical column Diamonsil C18 column(4.6 mm×250 mm,5μm)was adopted,and the mobile phase was acetonitrile-water(35∶65)at the flow rate of 1.0 mL/min,and the column temperature was 30℃.The flow rate was 2.5 L/min,and the temperature of drift tube was 105℃.Results:The linear range of Astragaloside Ⅳ was 0.404~12.12μg(r=0.9999),and the average recovery(n=6)was 95.5%.Conclusion:The quantitative method is accurate and highly reproducible,and can be used for quality control of Shenkangning granules.

关 键 词：肾康宁颗粒 HPLC-ELSD法 黄芪甲苷 质量控制 

分 类 号：R286.0[医药卫生—中药学]