Simultaneous determination of 15 marker constituents in various radix Astragali preparations by solid-phase extraction and high-performance liquid chromatography.
An improved quality control method was developed to simultaneously determine 15 major constituents (eight flavonoids and seven saponins) in various radix Astragali preparations, using SPE for pretreatment of samples, HPLC with diode-array and evaporative light scattering detectors (DAD-ELSD) for quantification in one run, and HPLC-ESI-TOF/MS for definite identification of compounds in preparations. Optimum separations were obtained with a ZORBAX C(18) column, using a gradient elution with 0.3% aqueous formic acid and ACN. This established method was fully validated with respect to linearity, precision, repeatability, and accuracy, and was successfully applied to quantify the 15 compounds in 19 commercial samples, including 3 dosage forms, i. e., oral solution, injection, concentrated granule, and its processed products of radix Astragali. The results demonstrated that many factors might result in significant differences in quality of the final preparations, including crude drugs, pretreatment processes, manufacturing procedure, storage conditions, etc. Then the developed method provided a reasonable and powerful manner to ensure the efficacy, safety, and batch-to-batch uniformity of radix Astragali products by standardizing each procedure, and thus should be proposed as quality control for the clinical use and modernization of herbal preparations.
Qi
Lian-Wen
LW
Key Laboratory of Modern Chinese Medicines, China Pharmaceutical University, Ministry of Education, Nanjing, People's Republic of China.
Yu
Qing-Tao
QT
Yi
Ling
L
Ren
Mei-Ting
MT
Wen
Xiao-Dong
XD
Wang
Yu-Xia
YX
Li
Ping
P
D027883:Astragalus Plant / Q000737:chemistry*; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D008516:Medicine, Chinese Traditional; D015394:Molecular Structure; D015203:Reproducibility of Results; D052616:Solid Phase Extraction / Q000379:methods*