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.