Establishing a reference standard of Paeoniflorin isolated from Radix Paeoniae Lactiflorae

Lam Hong Nguyen , Thu Trang Pham

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Abstract

In China and Viet Nam, Radix Paeoniae lactiflorae is a medicinal herb commonly used in traditional medicine. Nowadays, Radix Paeoniae lactiflorae has also been studied in modern medicine. In the Radix Paeoniae lactiflorae monograph of the Vietnam Pharmacopoeia V, its paeoniflorin content quantified by HPLC/DAD, is specified to be not less than 1.6%. For the quality control of Radix Paeoniae lactiflorae, the establishment of paeoniflorin as an affordable-price reference standard is a prerequisite in Vietnam. In this study, 3.2 g of paeoniflorin was isolated and purified from 1.5 kg of Radix Paeoniae lactiflorae. The purified substance, whose structure was confirmed as paeoniflorin by 1H, 13C-NMR, HR-MS, IR, was established as a reference standard in the Laboratory for Establishment of Reference Substances, National Institute of Drug Quality Control, and packaged in 10-mg standard tubes. The content of astragaloside IV in our purified samples was determined to be 91.5% by HPLC/DAD analysis, with an expanded measurement uncertainty U = ± 0.31%

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References

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