Quantitative Determination of 7 Saikosaponins in Xiaochaihu Granules Using High-Performance Liquid Chromatography...

Bupleuri Radix (Chaihu, in Chinese) is the principal drug in Xiaochaihu granules (XGs) that is a famous Chinese medicine preparation in China. Since previous analytical methods have not focused on the multiactive saikosaponins of Chaihu, it is difficult to effectively control the quality of XG on the market. In this manuscript, the simultaneous determination of 7 saikosaponins (saikosaponins C, I, H, A, B₂, G, and B₁) in XG by HPLC with charged aerosol detection (CAD) and confirmation by LC-Q-Orbitrap HRMS were described. The saikosaponins were purified on an SPE cartridge and determined on a Waters CORTECTS C18 column (4.6 mm × 150 mm, 2.7 μm) by gradient elution using 0.01% acetic acid aqueous solution and acetonitrile. The results showed good linearity with the r ² values higher than 0.998 for all analytes. The average recoveries at three different concentration levels ranged from 80% to 109% and the intraday and interday precision (relative standard deviations, RSD%) were in the range of 1.0%∼1.9% and 1.4%∼2.1%, respectively. The established HPLC-CAD method was subsequently applied to 15 batches of XG to investigate the batch-to-batch consistency and controllability. The proposed method could potentially be used for the quality control of XG and also be helpful in the quality evaluation of Chaihu and its related preparations.