全谱二维液相色谱检测丹参中的活性成分

Determination of active components in Salvia miltiorrhiza by Polarity Partition two-dimensional liquid chromatography

本文利用岛津全谱二维液相色谱系统,建立了一针进样分析丹参中脂溶性和水溶性活性成分的液相色谱方法.相对于2020年版《中华人民共和国药典》需要分两个方法进行分析,本方法仅用21 min,可以实现丹参酮ⅡA、隐丹参酮、丹参酮Ⅰ和丹酚酸B的同时分离,分离度良好,满足药典要求.方法学验证结果表明,4种成分在线性范围内相关性良好,线性相关系数均大于0.999;连续6次重复进样分析中,4种成分的保留时间的RSD在0.018%—0.085%之间,峰面积的RSD在0.10%—0.38%之间,说明本方法稳定性良好.加标回收实验,4种成分的加标回收在89.63%—118.15%之间,RSD在0.31%—4.99%之间.使用本方法检测某丹参样品含量,平行6次分析结果的RSD在2.64%—4.21%之间.

In this paper,polarity partition two-dimensional liquid chromatography system was used to establish a liquid chromatography method for the analysis of four active components,i.e.tanshinone IIA,cryptotanshinone,tanshinone I and salvianolic acid B,in Salvia miltiorrhiza with different polarity.Compared with the 2020 edition of the Pharmacopoeia of the people’s Republic of China,the analysis needs to be divided into two methods.Our method only takes 21 minutes,which can not only realize the simultaneous separation of the four active components,but also has good separation and meets the requirements of the Pharmacopoeia.The results of methodological validation showed that the four components had good correlation in the linear range,and the linear correlation coefficient was greater than 0.999;In six consecutive repeated injection analysis,the RSD of the retention time of the four components is between 0.018%—0.085%,and the RSD of the peak area is between 0.10%—0.38%,indicating that the method is stable.In the standard addition recovery experiment,the standard addition recovery of the four components is between 89.63%—118.15%,and the RSD are between 0.31%—4.99%.The RSD of six parallel analysis results are between2.64%—4.31%.