Determination of Berberine Hydrochloride and Total Glucosides of Paeony by 1H NMR for Quality Control of Fufang Huangliansu Commercial Products

“Fufang huangliansu” prescription, as a Chinese patent herbal medicine, is widely applied in clinical practice, and its main physiologically active components are berberine hydrochloride and total glucosides of paeony. In this study, a rapid, simple, and accurate quantitative 1 H NMR method was developed and validated to determine the two main components of “fufang huangliansu” prescription, berberine hydrochloride and total glucosides of paeony. Dimethyl terephthalate was selected as an internal standard, and the signals for berberine hydrochloride at δ 8.94 ppm (H-13) and total glucosides of paeony at δ 7.55 ppm (H-3″, 5″) were selected for the construction of calibration curves. Method validation was performed in terms of specificity, precision, accuracy, repeatability, stability, and linearity. The results indicated that the assay was precise and in line with the China Food and Drug Administration guidance. The assay has been successfully applied to determine the content of berberine hydrochloride and total glucosides of paeony in “fufang huangliansu” obtained from two pharmaceutical companies. This finding indicates that this 1 H NMR method has the potential as a reliable method for quality control of Chinese patent medicines containing berberine. Graphical abstract