TY - JOUR
T1 - Combinative method using HPLC quantitative and qualitative analyses for quality consistency assessment of a herbal medicinal preparation
AU - Xie, Ying
AU - JIANG, Zhi Hong
AU - Zhou, Hua
AU - Cai, Xiong
AU - Wong, Yuen Fan
AU - Liu, Zhong Qiu
AU - BIAN, Zhaoxiang
AU - Xu, Hong Xi
AU - LIU, Liang
N1 - Funding Information:
This research was funded by the Hong Kong Jockey Club Charities Trust. The authors wish to thank Dr. Martha Dahlen for her professional English editing for this paper.
PY - 2007/1/4
Y1 - 2007/1/4
N2 - 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.
AB - 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.
KW - Fingerprinting analysis
KW - Herbal preparation
KW - HPLC-DAD
KW - Quality control
KW - Quantitative determination
UR - http://www.scopus.com/inward/record.url?scp=33845202375&partnerID=8YFLogxK
U2 - 10.1016/j.jpba.2006.07.008
DO - 10.1016/j.jpba.2006.07.008
M3 - Journal article
C2 - 16920317
AN - SCOPUS:33845202375
SN - 0731-7085
VL - 43
SP - 204
EP - 212
JO - Journal of Pharmaceutical and Biomedical Analysis
JF - Journal of Pharmaceutical and Biomedical Analysis
IS - 1
ER -