HPLC法测定香丹注射液中丹参素、原儿茶醛、咖啡酸、迷迭香酸、丹酚酸B和丹酚酸A(英文)

Simultaneous determination of danshensu,protocatechuic aldehyde,caffeic acid,rosmarinci acid,salvianolic acid B,and salvianolic acid A in Xiangdan Injection by HPLC

目的建立用高效液相色谱同时测定香丹注射液中丹参素、原儿茶醛、咖啡酸、迷迭香酸、丹酚酸B和丹酚酸A6个水溶性成分的方法,并对20个生产厂家香丹注射液进行测定。方法采用HPLC色谱系统,All-tima C18(250mm×4.6mm,5μm);流动相为乙腈-0.026%磷酸,梯度洗脱;流速为1.0mL/min;柱温25℃;检测波长为288nm。结果本方法6个成分色谱峰之间具有良好的分离度,它们的浓度和各自峰面积之间有着良好的线性关系,精密度、稳定性、重复性及加样回收率均符合要求。不同厂家香丹注射液中化学成分的含量存在较大差异,其中丹酚酸A量差异最大,丹参素差异最小。结论本方法能同时测定香丹注射液中6个主要化学成分,可为全面控制香丹注射液的质量提供参考。

Objective To establish an HPLC method to determine simultaneously the content of six water-soluble chemical constituents (danshensu,protocatechuic aldehyde,caffeic acid,rosmarinci acid,salvianolic acid B,and salvianolic acid A) in Xiangdan Injection,and to compare their content discrepancy of Xiangdan Injection from 20 manufacturers.Methods The HPLC method was established.The column was Alltima C18 (250 mm×4.6 mm,5 μm) at the gradient elution mode with the flow rate of 1.0 mL/min,column temperature was kept at 25 ℃ and the detector was set at 288 nm.Results Six components were separated clearly.The relationship between the concentration and the peak areas of the six compounds was all linear.The precision,stability,repetition,and average recovery were complied with the limit.Significant difference was found in contents of six chemical constituents in Xiangdan Injections from different manufacturers that the variation of salvianolic acid A content was the most distinct and danshensu was the most quietly.Conclusion The method has been successfully used to quanlify the six compounds in Xiangdan Injection,and then,can offer the reference for the quality control of Xiangdan Injections roundly.