Study on the quality standard of Qingre-Chushi granules

Abstract

Objective To study the quality standard of Qingre-Chushi granules, including TLC identification of main components and ultra performance liquid chromatography determination of main components, so as to lay a foundation for further development of new drugs. Methods Seven constituents, including Gentianae Radix et Razoma, Scutellaria Radix, Plantaginis Herba, Rehmanniae Radix, Imperarae Rhizoma, Poria and Glycyrrhiza Radix et Rhizoma, were determined by TLC. The content of gentiopicroside and Baicalin in Gentiana officinalis and Scutellaria baicalensis was determined by UPLC on Acquity UPLC HSS T3C18 column (2.1 mm×100 mm, 1.7 μm) with acetonitrile-0.01% formic acid water as mobile phase and gradient elution. Results TLC was highly specific and could effectively identify Gentian, Scutellaria baicalensis, Plantain, Rehmannia glutinosa, Rhizoma cocos, and licorice. The results of UPLC assay showed that there was a good linear relationship between gentiopicroside and Baicalin in the range of 0.014-0.028 μg and 0.015-0.449 μg, and the recovery of the three concentrations were all up to standard. Conclusions TLC can be used to identify the seven components of Qingre-Chushi granules, and UPLC can be used to determine the contents of three indicators, which can control the quality of Qingre-Chushi granules. Key words: Quality control; Chromatography, thin layer; Ultra performance liquid chromatography; Qingre-Chushi granules