Quality control for nine components in Yiqi Fumai Injection based on quantitative analysis of multi-components with a single-marker / 中草药

ABSTRACT

Objective To establish a quantitative analysis of multi-components with a single-marker (QAMS) method for the determination of nine components in Yiqi Fumai Injection (YFI). Methods Ginsenoside Rb1 was used as internal reference substance. The relative correlation factors (f) of ginsenosides Rg1, Re, Rf, Rc, Ro, Rb2, Rd, and schisandrin were calculated and established by HPLC. The separation was performed on a Diamonsil® C18 column (2) (250 mm × 4.6 mm, 5 μm), with the mobile phase consisting of acetonitrile and 0.05% phosphoric acid water for gradient elution. The column temperature was 30 ℃, and the detection wavelength was set at 203 nm, flow rate was 1 mL/min. The results were compared with those obtained by the external standard method in 25 batches of YFI. Results Ginsenosides Rg1, Re, Rf, Rb1, Rc, Ro, Rb2, Rd, and schisandrin had good relations within the ranges of 0.929-4.644, 0.818-4.089, 0.732-3.660, 1.461-7.305, 0.636-3.181, 0.618-3.092, 0.788-3.941, 0.758-3.789, and 0.178-0.889 μg, respectively. The recovery rates were 97.08%-100.94%. The f values of ginsenosides Rg1, Re, Rf, Rc, Ro, Rb2, Rd, and schisandrin to ginsenoside Rb1 were 1.970, 0.929, 1.196, 0.870, 0.830, 0.786, 0.906, and 12.082. The two methods did not show the significant difference in assay results. Conclusion The QAMS method is feasible and credible, and could be used to determine the multiple components in YFI.