齐墩果酸片的含量测定  

Determination of oleanolic acid in oleanolic acid tablets by HPLC

作　　者：周震宇 沈心 ZHOU Zhenyu;SHEN Xin(Suzhou Institute for Drug Control,Suzhou 215014,China)

机构地区：[1]苏州市药品检验检测研究中心

出　　处：《中国药品标准》2019年第6期505-509,共5页Drug Standards of China

摘　　要：目的:建立齐敦果酸片中齐墩果酸含量测定的方法。方法:采用YMC-Pack ODS-A色谱柱(4.6 mm×250 mm,5μm);以0.1%醋酸铵水溶液-乙腈(85∶15)为流动相,等度洗脱;流量1.0 mL·min^-1;检测波长210 nm;柱温35℃;进样量10μL。结果:齐墩果酸的浓度在10~1000μg·mL^-1范围内与峰面积呈良好的线性关系(r=0.9999),平均回收率为99.97%,其RSD为1.43%(n=9)。结论:该方法简便、快速,可用于齐敦果酸片中齐敦果酸的含量测定。Objective:To establish an HPLC method for determination of oleanolic acid in oleanolic acid tablets.Methods:The separation was performed in a YMC-Pack ODS-A column(4.6 mm×250 mm,5μm)under isocratice elution of 0.1%ammonium acetatesolution-acetonitrile(85∶15).The flow rate was 1.0 mL·min^-1,and the detection wavelength was set as 210 nm.The column temperature was 35℃and the injection volume was 10μL.Results:There was the good linearity between the peak area and concentration of oleanolic acid in the range of 10-1000μg·mL^-1(r=0.9999).The average recovery was 99.97%with RSD as 1.43%(n=9).Conclusion:The established method is simple and rapid,and it can be adopted for assay of oleanolic acid tablets.

关 键 词：齐墩果酸片 齐敦果酸 含量测定 高效液相色谱法 

分 类 号：R921.2[医药卫生—药学]