高效液相色谱法测定六味地黄胶囊中熊果酸的含量  

Determination of Ursolic Acid in Liuwei Dihuang Capsules by HPLC

作　　者：郭文婷 GUO Wen-ting(Kunming Institute for Food and Drug Control,Yunnan Kunming 650032,China)

机构地区：[1]昆明市食品药品检验所,云南昆明650032

出　　处：《广州化工》2024年第18期114-116,共3页GuangZhou Chemical Industry

摘　　要：为建立质控指标,有效控制药品质量,建立高效液相色谱法测定六味地黄胶囊中熊果酸的含量。色谱柱为Agilent zorbax SB18柱(4.6 mm×150 mm, 5μm),流动相为乙腈-甲醇-0.5%乙酸胺(60∶12∶28),流速为1.0 mL·min^(-1),检测波长为215 nm,柱温为25℃。熊果酸在0.050 88~0.254 4 mg·mL-1的范围内与峰面积呈良好线性关系,熊果酸回收率为95.87%,RSD为0.67%,方法重复性良好,RSD为1.8%,12 h稳定性的RSD为1.6%,结果表明此方法高效便捷,为熊果酸含量测定提供了依据。To establish the quality control index and effectively control the drug quality,a HPLC method was established to determine the ursolic acid content in Liuwei Dihuang Capsule.Chromatographic column was Agilent zorbax SB 18 column(4.6 mm×150 mm,5μm),mobile phase was acetonitrile-methanol-0.5%amine acetate(60∶12∶28),flow rate was 1.0 mL·min^(-1),detection wavelength was 215 nm and column temperature was 25℃.Ursolic acid had a good linear relationship with peak area in the range of 0.05088~0.2544 mg·mL-1.The recovery rate of ursolic acid was 95.87%,RSD was 0.67%.Repeatability was good,RSD was 1.8%,RSD of 12 h stability was 1.6%.The results showed that this method was efficient and convenient,which provided a basis for the determination of ursolic acid content.

关 键 词：高效液相色谱法 六味地黄胶囊 熊果酸 含量测定 

分 类 号：R284[医药卫生—中药学]