摘要
目的:建立高效液相色谱法测定心可舒胶囊中丹酚酸B的定量分析方法。方法:采用Apollo C 18色谱柱(4.6 mm×250 mm,5μm),以甲醇-乙腈-甲酸-水(24∶10∶1∶65)作为流动相进行洗脱,流速0.8 mL·min^-1,柱温35℃,检测波长286 nm。结果:丹酚酸B在0.220~2.203μg(r=1.0000)范围内线性关系良好,回收率为98.47%,RSD为0.4%。12批次心可舒胶囊中丹酚酸B含量为0.05~1.70 mg/粒。结论:该方法专属性强,结果准确可靠,重现性好,可用于心可舒胶囊的质量控制。
Objective:To establish the method for determining the content of salvianolic acid B in Xinkeshu capsules by HPLC.Methods:The determination was performed on Apollo C 18(4.6 mm×250 mm,5μm).The mobile phase was methanol,acetonitrile methanoic acid and water(24∶10∶1∶65)with the flow rate of 0.8 mL·min^-1,the temperature of 35℃and detection wavelength of 286 nm.Results:The linear ranges of salvianolic acid B was 0.220-2.203μg(r=1.0000).The average recovery was 98.47%with RSD 0.4%(n=6).The contents of salvianolic acid B in 12 samples were 0.05-1.70 mg per capsule.Conclusion:The method is highly specific,accurate and reliable and repeatable.It is suitable for the quality control of Xinkeshu capsules.
作者
杨献玲
王海洋
姜泽
YANG Xianling;WANG Haiyang;JIANG Ze(Jilin Institute for Drug Control,Changchun,130033,China)
出处
《中国药品标准》
CAS
2020年第6期567-570,共4页
Drug Standards of China