注射用丹酚酸A相关物质分析研究

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,5 μm)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.