Combinative method using HPLC quantitative and qualitative analyses for quality consistency assessment of a herbal medicinal preparation.
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.
Xie
Ying
Y
School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong, China.
Jiang
Zhi-Hong
ZH
Zhou
Hua
H
Cai
Xiong
X
Wong
Yuen-Fan
YF
Liu
Zhong-Qiu
ZQ
Bian
Zhao-Xiang
ZX
Xu
Hong-Xi
HX
Liu
Liang
L
D000157:Aconitine / Q000032:analysis; D002851:Chromatography, High Pressure Liquid; D004365:Drugs, Chinese Herbal / Q000032:analysis*; D007202:Indicators and Reagents; D010777:Photochemistry; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
D004365:Drugs, Chinese Herbal; D007202:Indicators and Reagents; C520667:qingfu guanjieshu; D000157:Aconitine