Quantitative Study on Simultaneous Determination of Nine Components in Renshen Nüjin Pills Based on QAMS / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish a quantitative analysis of multi-components by single-marker (QAMS) method for simultaneous determination of senkyunolide H, senkyunolide I, senkyunolide A, ligustilide, oxypaeoniflorin, albiflorin, paeoniflorin, benzoylpaeoniflorin and α-cyperone in Renshen Nüjin pills, in order to provide basis for studying its quality standards.METHODS: The analysis of the methanol extract of Renshen Nüjin pills was performed on Agilent Zorbax SB C18 column (4.6 mm×250 mm,5 μm), with mobile phase composed of methanol-acetonitrile (2∶1)-0.1% phosphoric acid solution at a flow rate of 0.9 mL•min-1 in gradient elution mode. The column temperature was maintained at 30 ℃, and the detection wavelengths were set at 280, 230 and 242 nm. Paeoniflorin was selected as the internal standard, and the relative correlation factors (RCF) of senkyunolide H, senkyunolide I, senkyunolide A, ligustilide, oxypaeoniflorin, albiflorin, paeoniflorin, benzoylpaeoniflorin and α-cyperone were determined by HPLC. The accuracy and feasibility of the method were validated by comparing the results of QAMS method and external standard method.RESULTS: The standard curves of senkyunolide H, senkyunolide I, senkyunolide A, ligustilide, oxypaeoniflorin, albiflorin, paeoniflorin, benzoylpaeoniflorin and α-cyperone had good linear relationship in the ranges of the tested concentrations. The precision, stability and repeatability complied with the requirements of methodology. The recoveries were 97.38%, 98.16%, 98.84%, 99.63%, 97.04%, 99.14%, 100.04%, 96.93% and 98.48%, RSDs were 1.38%, 1.18%, 0.97%, 0.86%, 1.68%, 1.30%, 0.57%, 1.32% and 1.19%, respectively. No significant differences were observed in the determination results by QAMS method and external standard method.CONCLUSION: The QAMS method can be used for the content determination and quality control of the nine components in Renshen Nüjin pills.