Combined Application of UHPLC-QTOF/MS, HPLC-ELSD and H-NMR Spectroscopy for Quality Assessment of DA-9801, A Standardised Dioscorea Extract.

Introduction: DA-9801, a standardised 50% aqueous ethanolic extract of a mixture of Dioscorea japonica and D. nipponica, is a botanical drug candidate for the treatment of diabetic neuropathy, which finished its US phase II clinical trials recently. An advanced quality control method is needed for further development of DA-9801, considering its high contents of both primary and secondary metabolites.