丹香冠心注射液HPLC指纹图谱及4种成分的含量测定

目的:建立丹香冠心注射液的HPLC指纹图谱,并测定其中4种有效成分的含量.方法:采用Agilent TC-C18色谱柱;流动相为乙腈-0.05%三氟乙酸水溶液,梯度洗脱;检测波长288 nm;流速1.0 mL·min-1;柱温40℃.通过中药色谱指纹图谱相似度评价系统进行相似度评价.结果:标定了13个共有峰,10批样品的相似度均大于0.98;测定了10批样品中丹参素钠、原儿茶醛、迷迭香酸、丹酚酸B的含量,4种成分在标准曲线范围内线性关系良好(r>0.999),平均回收率均大于97%(n=6).结论:该方法简便、快速、准确,可用于该品的质量控制.

Danxiang Guanxin Injection; Determination; Fingerprint; HPLC

Objective: To establish an HPLC method for the fingerprint and determination of 4 active components in Danxiang Guanxin Injections. Methods: An Agilent TC-C18 ccolumn was used, the mobile phase was acetonitrile-0.05% trifluoroacetic acid (TFA) for gradient elution, the detection wavelength was 288 nm, the flow rate was 1 mL·min-1 and the column temperature was 40℃. The Similarity Evaluation System for Chromatographic Fingerprint of TCM was used to evaluate the similarity. Results: There were 13 common peaks; the similarity of 10 samples was over 0.98. The contents of danshensu-sodium, protocatechuic aldehyde, rosmarinic acid and salvianolic acid B were determined in the 10 samples. Within detection ranges of the 4 components, standard curves were linear (r>0.999), average recovery rates were over 97% (n=6). Conclusion: The method is simple, rapid and accurate, which can be used for the quality control of Danxiang Guanxin Injections.