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.
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)
出处
《药品评价》
CAS
2021年第19期1176-1178,共3页
Drug Evaluation
