Combinative method using HPLC quantitative and qualitative analyses for quality consistency assessment of a herbal medicinal preparation

Ying Xie, Zhi Hong JIANG, Hua Zhou, Xiong Cai, Yuen Fan Wong, Zhong Qiu Liu, Zhaoxiang BIAN, Hong Xi Xu, Liang LIU*

*Corresponding author for this work

Research output: Contribution to journalJournal articlepeer-review

72 Citations (Scopus)


A selective and efficient quality consistency assessment system was developed for monitoring the manufacturing processes of a Chinese herbal preparation, Qingfu Guanjieshu (QFGJS) capsule, and for assessing its stability over time. This system is based on quantitative determination of four marker compounds, i.e., sinomenine, paeoniflorin, paeonol, and curcumin, and on qualitative fingerprinting analysis of QFGJS using high-performance liquid chromatography-photodiode array detection (HPLC-DAD) method. The separation was performed on a Phenomenex ODS column by gradient elution with acetonitrile and aqueous phase (containing 0.1% phosphoric acid, adjusted with triethylamine to pH 3.5 ± 0.2) at a flow-rate of 1.0 ml/min. In fingerprinting analysis, the chemical characteristics of four herbs present in QFGJS (excluding Radix Aconiti Lateralis Preparata) were present in the HPLC chromatographic file. In addition, quantitative determination of hypaconitine was carried out with our published HPLC method as a supplement for quality control of the Radix Aconiti Lateralis Preparata in QFGJS. The results showed that the contents of these five marker compounds and HPLC fingerprint profiles of three batches of QFGJS products collected at 3 months after production in the stability testing were relatively consistent. This well-developed method could be used for quality assessment of the complex preparations of herbal medicine.

Original languageEnglish
Pages (from-to)204-212
Number of pages9
JournalJournal of Pharmaceutical and Biomedical Analysis
Issue number1
Publication statusPublished - 4 Jan 2007

Scopus Subject Areas

  • Analytical Chemistry
  • Pharmaceutical Science
  • Drug Discovery
  • Spectroscopy
  • Clinical Biochemistry

User-Defined Keywords

  • Fingerprinting analysis
  • Herbal preparation
  • Quality control
  • Quantitative determination


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