高效液相色谱法测定冠心宁冻干粉针剂中9个酚性成分的含量

HPLC determination of nine phenolic components in Guanxinning lyophilized powder for injection

目的:建立反相高效液相色谱法同时测定冠心宁冻干粉针剂中9个酚性成分(丹参素、原儿茶酸、原儿茶醛、绿原酸、咖啡酸、阿魏酸、异阿魏酸、迷迭香酸、丹酚酸B)的含量。方法:采用Luna C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-磷酸水溶液为流动相系统进行梯度洗脱,检测波长280 nm,柱温35℃。结果:待测组分在各自浓度范围内与峰面积呈良好线性关系,R2均大于0.99,平均回收率(n=9)分别在96.3%～104.3%之间。结论:测定方法准确、灵敏,重复性好,为全面评价冠心宁冻干粉针剂质量提供了可靠方法。

Objective：An effective,accurate and reliable method for the determination of nine phenolic components（danshensu,protocatechuic acid,protocatechuic aldehyde,chlorogenic acid,caffeic acid,ferulic acid,isoferulic acid,rosmarinic acid,salvianolic acid B） in Chinese medicine Guanxinning lyophilized powder for injection was developed.Methods：The separation,using reversed phase high-performance liquid chromatography（RP-HPLC）,was performed on a Luna C18 column（250 mm×4.6 mm with 5 μm particle size） with a gradient elution programme when the wavelength was 280 nm and the column temperature was 35 ℃.Results：Excellent linear behaviors over the investigated concentration ranges were observed with the value of R2 higher than 0.99 for all the analytes.The recoveries,measured at three concentration levels,varied from 96.3% to 104.3%.Conclusion：The method is accurate,reliable and effective for the simultaneous determination of nine phenolic components in Guanxinning lyophilized powder for injection.