Harmonization of methodological approaches to the standardization of the pharmacopoeial types of plant materials containing flavonoids

DOI: https://doi.org/10.29296/25419218-2020-05-01

I.A. Samylina(1), D.V. Moiseev(1, 2), S.I. Marchenko(3), O.A. Veremchuk(2), A.M. Moiseeva(2), A.A. Sorokina(1) 1-I.M. Sechenov First Moscow State Medical University (Sechenov University), 2, Bolshaya Pirogovskaya St., Build. 4, Moscow 119991, Russian Federation; 2-Vitebsk State Medical University, 27, Frunze Prospect, Vitebsk 210009, Republic of Belarus; 3-Center for Examinations and Tests in Health Service, 2a, Tovarishchesky Lane, Minsk, 220037, Republic of Belarus

The paper considers pharmacopoeial approaches to the standardization of flavonoid-containing medicinal plant raw materials (MPRM) from different manufacturers in the Eurasian Economic Union (EAEU) countries. Two or three countries produce 31 names of MPRMs that are standardized according to the content of flavonoids. The breadth of use of this MPRM creates prerequisites for including these types in the common EAEU pharmacopeia. It is proposed to standardize a number of MPRM types, such as birch (Betula) leaves, black elder (Sambucus nigra) flowers, knotweed (Polygonum aviculare) herb, marjoram (Oreganum) herb, common horsetail (Equisetum arvense) herb, and beggarticks (Bidens) herb, according to the content of flavonoids, by using the unified chromatographic conditions for their determination by high performance liquid chromatography (HPLC). Using a new MPRM type (common heather (Calluna vulgaris) shoots) as an example, the authors consider the main stages of HPLC assay validation, by quantifying the amount of flavonoids in the plant materials, as calculated with reference to the analytical marker

medicinal plant material

  1. State Pharmacopoeia of the Russian Federation XIV ed. [Electronic resource]. – Moscow, 2018. Mode of access: http://www.resourse.rucml.ru/feml/pharmacopeia/14_3/HTLM (circulation date: 20.03.19). (in Russian)
  2. State Pharmacopoeia of the Republic of Belarus: II edition, vol.2. Quality control of substances for pharmaceutical use and medicinal plant raw materials. Molodechno: Pobeda, 2016; 1368 (in Russian).
  3. State Pharmacopoeia of the Republic of Kazakhstan. First edition. Vol. 2. Almaty: Publishing house «Zhibek Zholy», 2009; 804 (in Russian).
  4. State Pharmacopoeia of the Republic of Kazakhstan. Vol. 3. Almaty: Publishing house «Zhibek Zholy», 2014; 872 (in Russian).
  5. Registered medicinal plant raw materials. [Electronic resource]. Mode of access: http://www.rceth.by (circulation date: 10.05.2019) (in Russian).
  6. Registered medicinal plant raw materials. [Electronic resource]. Mode of access: http://www.ndda.kz/category/Gosudarstvennyi_reesttr (circulation date: 10.05.2019) (in Russian).
  7. Registered medicinal plant raw materials [Electronic resource]. Mode of access: http://grls.rosminzdrav.ru/GRLS.aspx (circulation date: 10.05.2019). (in Russian).
  8. Moiseev D.V., Buzuk G.N., Shelyuto V.L. Identification of flavonoids in plants by HPLC. Khimiko-farmatsevticheskiy zhurnal. 2011; 45 (1): 47–50 (in Russian).
  9. Veremchuk O.A., Moiseev D.V. Validation of assay for determination of flavonoids in heather shoots. Vestnik of Vitebsk State Medical University, 2015; 14 (1): 128–35 (in Russian).
  10. Guidelines for validation of analytical methods of drug testing. Decision 113 of 17.07.2018. Moscow. [Electronic resource]. Mode of access: http://docs.eaeunion.org/docs/ru-ru/01418296/clcd_20072018_113 (circulation date: 09.12.19) (in Russian).
  11. Moiseev D.V., Marchenko S.I., Moiseeva A.M. Standardization of pharmacopoeial raw materials containing flavonoids by HPLC. Sbornik nauchnikh trudov «IV Hammerman readings». M.: RUSAINS, 2018; 225–8