Isolation, purification and standardzation of raw material of lobetyolin extracted from Radix Codonopsis Javanicae for reference standard establisment

Tóm tắt

Lobetyolin is a compound widely used as a marker for the quality control of medicinal materials derived from several species of the Codonopsis genus in the monographs of various pharmacopoeias. In Vietnam, research on the establishment of a lobetyolin reference substance remains limited, and such standards are mostly purchased from foreign sources. This study developed an efficient process for the isolation and purification of lobetyolin from Codonopsis javanica using liquid-liquid extraction, normal-phase column chromatography, and preparative reversed-phase HPLC. The overall yield for the isolation and purification process was 24.65%. After purification, the lobetyolin raw material was characterized and standardized using the following parameters: identification via IR and UV-Vis spectroscopy, loss on drying, melting point, specific optical rotation, related substances, and chromatographic purity. The analytical procedure for the determination of related substances and chromatographic purity was fully validated in compliance with ICH and AOAC International guidelines. With a lobetyolin content of 98.96% (w/w), the purified material obtained in this study is suitable for the establishment of a lobetyolin reference substance for quality control purposes.