DEVELOPMENT AND VALIDATION OF THE QUANTITATIVE ANALYSIS METHOD OF THE FLAVONIDS IN THE DRY EXTRACT OF PEONY GARDEN

DOI: https://doi.org/10.29296/25877313-2018-04-01
Issue: 
4
Year: 
2018

N.I. Nakaryakova Assistant, Perm State Pharmaceutical Academy of the Ministry of Health of the Russian Federation E-mail: nataly-5114@mail.ru E.N. Lyust Ph.D. (Pharm.), Perm State Pharmaceutical Academy of the Ministry of Health of the Russian Federation M.M. Smirnova Ph.D. (Pharm.), Perm State Pharmaceutical Academy of the Ministry of Health of the Russian Federation O.A. Oleshko Dr.Sc. (Pharm.), Perm State Pharmaceutical Academy of the Ministry of Health of the Russian Federation

Confirmation of the quality of medicinal products by analytical methods is necessary to ensure the effectiveness and safety of pharmaceutical products. Therefore, the development and validation of methods of quantitative analysis of biologically active substances is great importance. Flavonoids are one of the main group of active substances in the dry extract of peony garden. The artical is devoted to the development and validation score of spectrophotometric determination of flavonoids in the dry extract of peony garden. At the first a selection of solvent was used to improve the methodology for the quantitative analysis of flavonoids given in the state pharmacopoeia. It was found that the optimum solvent for the dry extract of peony is water purified. Thus, the optimal conditions for the quantitative determination of the amount of flavonoids in terms of rutin in the dry extract of peony were selected. The validation of the developed method was carried out according to the following indices: precision (repeatability), intralaboratory propriety (reproducibility), linearity, correctness. To study the precision of the technique, a repeatability was established. Repeatability characterizes the coincidence of the results of individual tests with repeated use. Reproducibility was evaluated on identical samples in one laboratory. The linearity of the method was established on the basis of quantitative determination results in proportion to the concentration of the analyte. To assess the correctness of the method of quantitative determination of flavonoids, a standard sample was used. As a result of the study it was established that the spectrophotometric determination of flavonoids in the dry extract of peony garden differs by the correctness, convergence, linearity, precision (repeatability) and reproducibility.

Keywords: 
Peony garden
dry extract
validation
flavonoids

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