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Эко-Вектор (Россия)

DEVELOPMENT AND VALIDATION OF A METHOD FOR THE QUANTITATIVE DETERMINATION OF 20-HYDROXYECDISONE IN THE SERRATULA CORONATA HERBAL DRY EXTRACT

DOI: https://doi.org/10.29296/25877313-2024-06-01
Issue: 
6
Year: 
2024

G.V. Adamov
Ph.D. (Pharm.), Laboratory of Atomic-Molecular Bioregulation and Selection
E-mail: grig.adamov@mail.ru; ORCID: 0000-0001-7347-175X
A.I. Radimich
Senior Research Scientist, Department of Chemistry of Natural Compounds
E-mail: vilarnii.radimich@mail.ru; ORCID: 0000-0002-1139-8902
O.L. Saybel
Dr.Sc. (Pharm.), Head of the Center for Chemistry and Pharmaceutical Technology
E-mail: olster@mail.ru; 0000-0001-8059-5064
All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (VILAR), Grina str. 7, Moscow, 117216, Russian Federation

Introduction. The development and validation of analytical methods are one of the most important stages in the development of a new drug. As part of the implementation of the scientific research plan, the VILAR has developed a method for obtaining a dry extract Serratula coronata herb and its adaptogenic activity has been proven. The purpose of the study was to develop and validate a method for the quantitative determination of 20-hydroxyecdysone to control the quality of the Serratula coronata herbal dry extract. Materials and methods. The object of the study is a dry extract obtained by extracting dried herb with 70% ethyl alcohol, subsequent concentration, purification with chloroform, liquid-liquid extraction with n-butanol and drying of butanol extracts. Results. As a result of the research, optimal analysis conditions were selected and validation was carried out, which made it possible to characterize it positively in terms of specificity, linearity, accuracy, reproducibility, and intra-laboratory precision. Conclusions. The developed method is suitable for the quantitative determination of 20-hydroxyecdysone in the Serratula coronata herbal dry extract and can be used in drawing up a regulatory document for this substance.
Keywords: 
validation
20-hydroxyecdysone
HPLC
Serratula coronata herbal extract.
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