Chromatographic fingerprinting and quantitative analysis for the quality evaluation of Xinkeshu tablet  

作　　者：Pei Wang Lian Li Hailong Yang Shijuan Cheng Yingzi Zeng Lei Nie Hengchang Zang 

机构地区：[1]National Glycoengineering Research Center and School of Pharmaceutical Sciences, Shandong University [2]Shandong Wohua Pharmaceutical Limited Company

出　　处：《Journal of Pharmaceutical Analysis》2012年第6期422-430,共9页药物分析学报（英文版）

基　　金：supported by the Major Projects of Independent Innovation Achievements of Shandong Province(No. 2010ZDZX1A0406);partly by the Scientific and Technological Projects of Shandong Province (No. 2009GG10002081);Independent Innovation Foundation of Shandong University(No. 2010TS054);Shandong Province Natural Science Foundation, China (No. ZR2011HM080)

摘　　要：A simple, sensitive and accurate method based on high performance liquid chromato- graphy （HPLC） with diode array detector （DAD） was developed and validated for systematic quality evaluation of one type of traditional Chinese medicine preparations named Xinkeshu （XKS） tablet. In this study, the chromatographic fingerprints of XKS tablet were developed first, 23 peaks were selected as the common peaks to evaluate the similarities among different batches of XKS samples, which were manufactured in a long time span of three years. Additionally, simultaneous quantification of six markers in XKS tablet, including Danshensu, Protocatechuic aldehyde, Puerarin, Daidzin, Salvianolic acid B and Daidzein, was performed. The validation results showed that the developed method was specific, accurate, precise and robust. The preliminary explanation on why a close similarity between fingerprints did not exactly mean similar contents of chemical components in samples was given. The contribution of each chromatographic peak to similarity was also evaluated. The developed method offers an efficient, reliable and practical approach for systematic quality evaluation of XKS tablet.A simple, sensitive and accurate method based on high performance liquid chromato- graphy （HPLC） with diode array detector （DAD） was developed and validated for systematic quality evaluation of one type of traditional Chinese medicine preparations named Xinkeshu （XKS） tablet. In this study, the chromatographic fingerprints of XKS tablet were developed first, 23 peaks were selected as the common peaks to evaluate the similarities among different batches of XKS samples, which were manufactured in a long time span of three years. Additionally, simultaneous quantification of six markers in XKS tablet, including Danshensu, Protocatechuic aldehyde, Puerarin, Daidzin, Salvianolic acid B and Daidzein, was performed. The validation results showed that the developed method was specific, accurate, precise and robust. The preliminary explanation on why a close similarity between fingerprints did not exactly mean similar contents of chemical components in samples was given. The contribution of each chromatographic peak to similarity was also evaluated. The developed method offers an efficient, reliable and practical approach for systematic quality evaluation of XKS tablet.

关 键 词：Fingerprint analysis Quality evaluation Multi-ingredient quanti-tative analysis Xinkeshu tablet High-performanceliquid chromatography 

分 类 号：R286[医药卫生—中药学]