Targeting Analysis of Gallic Acid and Bioactive Components in Xuebijing Injection with Loop-based Heart-cutting Two-dimensional Liquid Chromatography

Background: Traditional Chinese medicine has been widely used in China for a long time. As a new type of formulation, Traditional Chinese Medicine Injection (TCMI) is diffusely used clinically as a promising therapy for a variety of diseases in primary health care institutions of China, which has many advantages, such as functional reliability and speed of action. In particular, TCMI is very suitable for rescue in an emergency. Objective: The quantitation of gallic acid and bioactive components in Xuebijing injection. Methods: A rapid loop-based heart-cutting two-dimensional liquid chromatography method has been established and applied to the quantification of gallic acid and bioactive components in Xuebijing injection. Results: The method provided powerful separation and its performance has been verified by evaluation of transference (≥86.48%), accuracy (relative standard deviation ≤ 4.67%), recovery (≥95.44%), linearity (r2 ≥0.9993), and limit of quantification (≤ 1.66 μg/mL). Six compounds, gallic acid, hydroxysafflor yellow (HSYA A), ferulic acid, paeoniflorin, salvianolic acid B, and kaempferide, were identified with concentrations ranging from 0.35–1795.40 μg/mL in Xuebijing injection. Conclusion: The loop-based heart-cutting 2D-LC method established in this study may provide convenient and feasible approach for quality control of preparation and use of TCMI.