Chromatographic fingerprints and quantitative analysis for the quality evaluation of Bao-Yuan Decoction by ultra-performance liquid chromatography coupled with diode array and evaporative light scattering detection

Bao-Yuan Decoction (BYD), a widely used traditional Chinese medicine formula, is worth developing into modern dosage forms. To assess the quality of traditional decoction, the commonly used ultra-performance liquid chromatography coupled with diode array and evaporative light scattering detection (UPLC-DAD/ELSD) method was initially applied to develop the analytical methods for the qualitative fingerprints and simultaneous quantitation of multiple marker compounds in BYD. Based on 16 batches of BYD prepared from multiple batches of qualified crude herbs combined randomly, the characteristic fingerprints were generated, with 41 and 19 common peaks detected by DAD and ELSD, respectively. Furthermore, ginsenosides Re, Rg1 and Rb1, calycosin-7-glucoside, calycosin, liquiritin, isoliquiritin apioside, isoliquiritin, glycyrrhizic acid and cinnamic acid were qualified as marker compounds to represent the herbs composing the formula. The characteristic fingerprints and the content ranges of multiple batches of the decoction were obtained, thus providing guidance for the quality control of modern dosage forms. The combination of these qualitative and quantitative methods will be an effective operational measure by which to evaluate and control the quality of BYD from traditional decoction to modern dosage forms.