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目的:建立同时测定丹红注射液中丹参素、原儿茶醛、咖啡酸、迷迭香酸、丹酚酸B和丹酚酸A含量的高效液相色谱-二极管阵列检测器(HPLC-DAD)方法,运用紫外-可见分光光度法(UV-VIS)检测丹红注射液中有效部位(总黄酮)的含量。方法:丹红注射液中6种成分的定量采用Eclipse XDB-C18色谱柱(4.6mm×150mm,5μm);乙腈-0.1%磷酸水流动相;流速1.0mL/min;波长330nm、280nm;柱温30℃。有效部位以芦丁为对照品,UV-VIS法进行测定。结果:样品中6种成分良好分离,线性关系良好(R>0.999,n=6),平均加样回收率分别为98.98%,100.86%,100.44%,98.73%,101.35%,100.17%。10批丹红注射液每1mL含6种有效成分的总量>11.50mg;总黄酮>9.00mg。结论:该方法操作简单,结果准确,具有较好的重复性和稳定性,可为丹红注射液的质量控制提供参考。
Objective: To establish a high performance liquid chromatography-diode array detector (HPLC-DAD) for simultaneous determination of Danshensu, protocatechuic aldehyde, caffeic acid, rosmarinic acid, salvianolic acid B and salvianolic acid A in Danhong injection ) Method was used to detect the content of total flavonoids in Danhong injection by ultraviolet-visible spectrophotometry (UV-VIS). Methods: Six components of Danhong injection were quantified by Eclipse XDB-C18 column (4.6mm × 150mm, 5μm), mobile phase of acetonitrile-0.1% phosphoric acid water, flow rate of 1.0mL / min, wavelength of 330nm and 280nm, 30 ° C. Effective parts of rutin as a reference substance, UV-VIS method for determination. Results: The six components in the sample were well separated and the linearity was good (R> 0.999, n = 6). The average recoveries were 98.98%, 100.86%, 100.44%, 98.73%, 101.35% and 100.17%, respectively. Ten batches of Danhong injection containing 6 active ingredients per mL total amount> 11.50mg; total flavonoids> 9.00mg. Conclusion: The method is simple, accurate and reproducible. It can provide reference for the quality control of Danhong injection.