Establishment and validation of an HPLC quantification method for quality control of Semen Oroxyli

Semen Oroxyli is a medicinal plant widely used in traditional Chinese medicine. In this study, an improved and comprehensive analytical method suitable for QC of Semen Oroxyli was optimized and fully validated according to International Conference on Harmonization guidelines in terms of linearity, precision, and accuracy. With this method, four flavonoids in Semen Oroxyli plant material were simultaneously quantitatively analyzed for the first time. The sample treatment procedure and HPLC conditions were investigated and optimized. HPLC separation was carried out on a C18 column; the detection wavelength was set at 280 nm. The mobile phase was a two-phase system consisting of water, acetic acid, and acetonitrile using a linear gradient. The RSDs within levels and between levels, as well as within and between days, were less than the acceptance limit of 5% for the tested analytes. The mean recoveries of the four marker constituents were, respectively, 99.60, 101.8, 98.84, and 102.9%, with no significant difference from 100%. The validation data showed the developed method was suitable for the QC of the Semen Oroxyli plant material and products thereof.