title: Simultaneous Determination of Eight Phenolic Acids, Five Saponins and Four Tanshinones for Quality Control of Compound Preparations Containing Danshen-Sanqi Herb-pair by HPLC-DAD.
abstract: BACKGROUND
  The herb-pair,Salviaemiltiorrhizae(Danshen, DS) andPanaxnotoginseng(Sanqi,SQ), often occurs in traditional Chinese medicine prescriptions used for the treatment of cardiovascular diseases in clinics in Asian areas. Many commercial preparations containing the DS-SQ herb-pair were produced by various manufactures with the different production process. The raw materials were from different sources, which raised a challenge to control the quality of the herb-pair medicines.
  
  
  OBJECTIVE
  In this paper, a high-performance liquid chromatography (HPLC) method was developed to simultaneously determine seventeen bioactive components, including 8 phenolic acids, 4 tanshinones, and 5 saponins, for quality control of compound preparations containing DS-SQ herb-pair. The chromatographic separation was studied on an Ultimate™ XB-C18column (150 mm × 4.6 mmi.d., 3.5 μm) with a mobile phase composed of 0.5% aqueous acetic acid and acetonitrile using a gradient elution in 70 min.
  
  
  RESULTS
  The optimum detection wavelength was set at 288 nm for phenolic acids and tanshinones, and 203 nm for saponins. The method was validated sufficiently by examining the precision, recoveries, linearity, range, LOD and LOQ, and was successfully applied to quantify the seventeen compounds in five commercial preparations containing DS-SQ herb-pair.
  
  
  CONCLUSIONS
  It is the first time to report the rapid and simultaneous analysis of the seventeen compounds with the base-line separation of peaks for ginsenoside Rg1and Re in 70 min by routine HPLC. This HPLC method could be considered as good quality criteria to control the quality of preparations containing DS-SQ herb-pair.
  
  
  CONCLUSIONS
  An HPLC method was originally developed to simultaneously quantify 8 phenolic acids, 4 tanshinones and 5 saponins in DS-SQ herb-pair preparations.The rapid and simultaneous analysis of the 17 compounds with the base-line separation of peaks for ginsenoside Rg1and Re within 70 min was achieved for the first time by routine HPLC.The presented method was successfully applied to the quality control of five compound preparations containing DS-SQ herb-pair.Additionally, it found that the favorable dosage forms for prescriptions containing DS-SQ herb-pair could be solid preparations.Abbreviations used:DS:Salviae miltiorrhizae; SQ:Panaxnotoginseng; HPLC: high-performance liquid chromatography; DAD: diode array detector; LOD: limit of detection; LOQ: limit of quantification; TCMs: Traditional Chinese medicines; GDDP: Guanxin Danshen dripping pills; FDDP: Fufang Danshen dripping pills; FDT: Fufang Danshen tablets; FDC: Fufang Danshen capsules; GP: Guanxin pillsKey Messages:The HPLC-DAD analysis successfully fulfilled the simultaneous determination of 17 compounds (including three types of authentic bioactive components, 8 phenolic acids, 4 tanshinones, and 5 saponins) in DS-SQ herb-pair within 70 min with the routine HPLC for the first time. The results also demonstrated that solid preparations could be the favorable dosage forms for those prescriptions containing DS-SQ herb-pair due to the instability of saponins from SQ, when the components of DS and SQ were coexisting in solution. The study provides a promising tool for quality control of the preparations containing the DS-SQ herb-pair.
authors.affiliation: Department of Pharmaceutical Analysis, Faculty of Pharmacy, Fujian Medical University, No.1 Xueyuan Road, Minhou County, Fuzhou, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Yao
authors.affiliation: Department of Pharmaceutical Analysis, Faculty of Pharmacy, Fujian Medical University, No.1 Xueyuan Road, Minhou County, Fuzhou, China.
authors.forename: Xiaomei
authors.initials: X
authors.lastname: Huang
authors.affiliation: Department of Pharmaceutical Analysis, Faculty of Pharmacy, Fujian Medical University, No.1 Xueyuan Road, Minhou County, Fuzhou, China.
authors.forename: Shaoguang
authors.initials: S
authors.lastname: Li
authors.affiliation: Department of Pharmaceutical Analysis, Faculty of Pharmacy, Fujian Medical University, No.1 Xueyuan Road, Minhou County, Fuzhou, China.
authors.forename: Youjia
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Department of Pharmaceutical Analysis, Faculty of Pharmacy, Fujian Medical University, No.1 Xueyuan Road, Minhou County, Fuzhou, China.
authors.forename: Xinhua
authors.initials: X
authors.lastname: Lin
authors.affiliation: Department of Traditional Chinese Medicine Resource and Bee products, Fujian Agriculture and Forestry University, No.15 Shangxiadian Road, Fuzhou, China.
authors.forename: Peiying
authors.initials: P
authors.lastname: Shi
keywords: Compound preparations; danshen-sanqi herb-pair; high-performance liquid chromatography; quality control