摘要
目的:建立高效液相色谱法测定注射用丹酚酸A中相关物质。方法:采用德国MN-C18(4.6 mm×250 mm,5μm)色谱柱,以乙腈-0.2%乙酸水溶液为流动相进行梯度洗脱,流速1.0 mL.min-1,检测波长286 nm,对杂质进行了定量研究。并采用制备液相色谱对主要杂质进行分离,进行了结构确证。结果:建立注射用丹酚酸A的相关物质检测方法,并分离确定了2个杂质的结构。结论:本法可用于注射用丹酚酸A相关物质的检测。
Objective：To develop a method for determination of related substances in salvianolic acid A for injection.Methods：HPLC was carried out for quantitative researches of impurities on an MN-C18 column（4.6 mm×250 mm,5 μm）.The mobile phase was acetonitrile-water（containing 0.2% acetic acid）with gradient elution.The flow rate was 1.0 mL·min-1,and the dection wavelength was 268 nm.The major impurities were were seperated by preparative liquid chromatography and identified by neclear magnetic resonance（NMR）.Results：A method for determination of related substances in salvianolic acid A for injection was established.Two impurities were seperated and identified.Conclusion：The established method can be used for the determination of related substances in salvianolic acid A for injection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2011年第2期348-351,共4页
Chinese Journal of Pharmaceutical Analysis
基金
北京高成长企业自主创新科技专项项目(Z08010202420873)
关键词
注射用丹酚酸A
相关物质
丹酚酸C
丹酚酸F
salvianolic acid A for injection
related substances
salvianolic acid C
salvianolic acid F
