HPLC法测定丹红注射液中4种水溶性成分的含量

目的 建立测定丹红注射液中丹参素钠、原儿茶醛、丹酚酸B、迷迭香酸4种水溶性成分含量的方法.方法 采用HPLC法,色谱柱为Kromasil C18；乙腈和0.05％磷酸溶液为流动相,进行梯度洗脱；流速为1 mL·min-1;检测波长为286 nm.结果 丹参素钠、原儿茶醛、丹酚酸B和迷迭香酸4种成分进样量分别在0.321～3.531μg、0.144～0.865μg、0.359～1.796μg、0.134～0.668μg范围内线性关系良好,平均回收率分别为100.75％(RSD=0.89％)、100.29％(RSD=1.43％)、99.23％(RSD=0.26％)和97.36％ (RSD=0.27％).结论 该方法简便、准确,可用于丹红注射液的质量控制.

Determination of Four Hydrosoluble Components in Danhong Injection by HPLC

Objective To establish a method for determination of sodium danshensu,protocatechuic aldehyde,salvianolic acid B and rosmarinic acid in Danhong injection.Methods The HPLC method was adopted with Kromasil C18 column;the mobile phase consisted of acetonitrile and 0.05% phosphoric acid solution in which the gradient elution started at a flow rate of 1.0 mL·min-1;the detection wavelength was 286 nm.Results The linear ranges of sodium danshensu,protocatechuic aldehyde,salvianolic acid B and rosmarinic acid were 0.321～3.531 μg,0.144～0.865 μg,0.359～1.796 μg and 0.134～0.668 μg,respectively.The average recoveries of sodium danshensu,protocatechuic aldehyde,salvianolic acid B and rosmarinic acid were 100.75%（RSD=0.89%）,100.29%（RSD=1.43%）,99.23%（RSD=0.26%） and 97.36%（RSD=0.27%）,respectively.Conclusion The method is simple,accurate,and can be applied to the quality control of Danhong injection.