Quality control for eight components in Guishao Zhenxian Tablets 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 simultaneous determination of oxypaeoniflorin, albiflorin, paeoniflorin, benzoylpaeoniflorin, cinnamic acid, cinnamaldehyde, saikosaponin a, and saikosaponin d in Guishao Zhenxian Tablets (GZT). Methods The separation was performed on a Thermo ODS C18 column (250 mm × 4.6 mm, 5 μm), with the mobile phase consisting of acetonitrile-0.1% phosphate acid solution for gradient elution. The column temperature was 25 ℃, and flow rate was 1.1 mL/min. Using paeoniflorin as internal reference substance, the relative correlation factors of oxypaeoniflorin, albiflorin, benzoylpaeoniflorin, cinnamic acid, cinnamaldehyde, saikosaponin a, and saikosaponin d were calculated and established by HPLC. The results were compared with those obtained by the external standard method to verify the rationality, feasibility, and repeatability of QAMS method. Results Oxypaeoniflorin, albiflorin, paeoniflorin, benzoylpaeoniflorin, cinnamic acid, cinnamaldehyde, saikosaponin a, and saikosaponin d had good relations within the ranges of 2.63-65.75 μg/mL (r = 0.999 7), 9.67-241.75 μg/mL (r = 0.999 8), 13.59-339.75 μg/mL (r = 0.999 5), 1.79-44.75 μg/mL (r = 0.999 4), 2.45-61.25 μg/mL (r = 0.999 1), 7.98-199.50 μg/mL (r = 0.999 7), 2.79-69.75 μg/mL (r = 0.999 3), and 2.51-62.75 μg/mL ( r= 0.999 5), respectively. The recovery rates were 98.64%, 99.33%, 100.02%, 97.42%, 96.95%, 98.75%, 98.21%, and 97.81%, RSDs were 0.89%, 1.19%, 1.00%, 1.33%, 1.51%, 0.99%, 1.43%, and 0.80%, respectively. The relative correlation factors values of oxypaeoniflorin, albiflorin, benzoylpaeoniflorin, cinnamic acid, cinnamaldehyde, saikosaponin a, and saikosaponin d to paeoniflorin were 0.520 9, 1.086 9, 0.476 8, 0.626 1, 0.802 1, 0.713 8, and 0.367 0, respectively. There were no significant difference in assay results between QAMS and the external standard method. Conclusion The QAMS method is feasible and credible, and could be used to determine oxypaeoniflorin, albiflorin, paeoniflorin, benzoylpaeoniflorin, cinnamic acid, cinnamaldehyde, saikosaponin a, and saikosaponin d in Guishao Zhenxian Tablets for the quality control.