Document Type

Journal Article

Department/Unit

School of Chinese Medicine

Title

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

Language

English

Abstract

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. © 2006 Elsevier B.V. All rights reserved.

Keywords

Fingerprinting analysis, Herbal preparation, HPLC-DAD, Quality control, Quantitative determination

Publication Date

2007

Source Publication Title

Journal of Pharmaceutical and Biomedical Analysis

Volume

43

Issue

1

Start Page

204

End Page

212

Publisher

Elsevier

DOI

10.1016/j.jpba.2006.07.008

Link to Publisher's Edition

http://dx.doi.org/10.1016/j.jpba.2006.07.008

ISSN (print)

07317085

ISSN (electronic)

1873264X

This document is currently not available here.

Share

COinS