HPLC法测定丹红注射液中丹酚酸B和迷迭香酸的含量

目的测定丹红注射液中丹酚酸B和迷迭香酸的含量,为该品种质量标准提高及产品质量评价提供试验依据。方法采用反相高效液相色谱法,色谱柱为Kromasil C18(250 mm×4.6 mm,5μm);乙腈为流动相A,0.05%磷酸溶液为流动相B,进行梯度洗脱;流速为1 mL.min-1;检测波长为286 nm。结果丹酚酸B进样在0.179 6~2.155 2μg间线性关系良好,加样回收率为100.42%(n=6);迷迭香酸进样在0.133 6~0.801 6μg间线性关系良好,加样回收率为99.27%(n=6)。结论该方法简便、准确、可靠,可用于标准提高,测定数据可作为质量评价依据。

Determination of the contents of salvianolic acid B and rosmarinic acid in Danhong Injection by HPLC

Objective To provide experimental basis for the improvement of the quality standard and evaluation of product quality of Danhong Injection by establishing a RP-HPLC method for determining the contents of salvianolic acid B and rosmarinic acid.Methods A Kromasil C18（250 mm×4.6 mm,5 μm）column was adopted with mobile phase consisted of acetonitrile and 0.05% phosphoric acid solution with gradient elution at a flow rate of 1.0 mL·min^-1,and the detection wavelength was 286 nm.Results The linear ranges of salvianolic acid B and rosmarinic acid were 0.179 6～2.155 2 μg,0.133 6～0.801 6 μg,and mean sample recovery rates were 100.42%（n=6）,99.27%（n=6）,respectively.Conclution The method was simple,accurate,and reliable for the improvement of the quality standard.The experimental data can be used as the basis of quality evaluation.