Improved quality control method for Fufang Danshen preparations through simultaneous determination of phenolic acids, saponins and diterpenoid quinones by HPLC coupled with diode array and evaporative light scattering detectors

J Pharm Biomed Anal. 2007 Dec 21;45(5):775-84. doi: 10.1016/j.jpba.2007.07.013. Epub 2007 Jul 20.

Abstract

A herb-combined prescription, mainly derived from roots of Salvia miltiorrhiza and Panax notoginseng, has been widely used for improving coronary or cerebral circulation in China as well as in Western countries. Multiple commercially available preparations, known as Fufang Danshen preparations (FDPs), produced by various manufacturers with the raw materials from different sources, pose a serious challenge to the quality control of this herb medicine. Previous pharmacological studies identify three types of bioactive components correlated with the clinical effect of those herb preparations. Those mainly include four phenolic acids, four saponins and four diterpenoid quinones. In this report, by using high performance liquid chromatography (HPLC) coupled with diode array and evaporative light scattering detectors (DAD-ELSD), we developed an improved quality control method for those herb medicines. A simultaneous separation and quantification of the 12 components was performed on a C(18) column, in which the mobile phase consisted of (A) 0.1% aqueous formic acid and (B) acetonitrile using a gradient elution. The optimum detection wavelength was set at 281 nm, the drift tube temperature of ELSD was set at 113 degrees C, the nitrogen flow rate at 3.1L/min, and the gain=4. All calibration curves showed good linear regression (r(2)>0.9927) within test ranges. The method developed showed good precision and accuracy with overall intra- and inter-day variations of 0.64-4.79% and 0.69-4.96%, respectively, and the overall recoveries of 93.50-107.69% for the 12 compounds analyzed. This method was successfully applied to quantify the twelve components in ten commercial samples from three formulas by seven independent manufacturers. This readily available, low-cost and reliable HPLC-DAD-ELSD method improved the quality control of traditional Chinese medicinal preparations consisting of complex compounds with different structures such as FDPs.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Calibration
  • Chromatography, High Pressure Liquid / methods*
  • Drug Stability
  • Drugs, Chinese Herbal*
  • Hydroxybenzoates / analysis*
  • Light
  • Medicine, Chinese Traditional*
  • Molecular Structure
  • Online Systems
  • Panax*
  • Plant Roots / chemistry
  • Quality Control
  • Quinones / analysis*
  • Reference Standards
  • Reproducibility of Results
  • Salvia miltiorrhiza / chemistry*
  • Saponins / analysis*
  • Scattering, Radiation
  • Sensitivity and Specificity
  • Temperature
  • Time Factors
  • Volatilization

Substances

  • Drugs, Chinese Herbal
  • Hydroxybenzoates
  • Quinones
  • Saponins
  • phenolic acid