Experimental research on development and validation of methods of quantitative determination of flavonoids and essential oil in solid multi-component capsules "Uroholum"

Authors

  • Oleksandr Shmalko National University of Pharmacy Pushkivska str., 53, Kharkiv, Ukraine, 61002, Ukraine
  • Nataliia Bevz National University of Pharmacy Pushkivska str., 53, Kharkiv, Ukraine, 61002, Ukraine https://orcid.org/0000-0002-7259-8908
  • Igor Vyshnevskyy Farmatsevtycheskaya Fabryka, Ooo Dkp Koroleva str., 4, Stanishivka, Zhytomyr Region, 12430, Ukraine
  • Liliia Vyshnevska National University of Pharmacy, Pushkivska str., 53, Kharkiv, Ukraine, 61002, Ukraine https://orcid.org/0000-0002-6887-3591

DOI:

https://doi.org/10.15587/2519-4852.2019.190552

Keywords:

standardization, multicomponent composition, dry extract, spectrophotometry, validation, solid capsules

Abstract

The aim. Development and validation of methods for the quantification of flavonoids and essential oils in solid multicomponent capsules for use in urology.

Methods. To quantify the amount of flavonoids, a spectrophotometric technique was developed and validated using an Evolution 60 s spectrophotometer from Thermo Fisher Scientific, USA, to determine the essential oil - gravimetric method.

Results. As a result of the study, a method was developed to quantify the sum of substances of the flavonoid structure of the total phytoextract in the form of capsules by spectrophotometric method and the sum of essential oils after pre-distillation with water vapour and extraction with organic solvent by gravimetry. Spectrophotometric quantification of flavonoid structure substances was performed after complexation reaction with aluminum salts (III) in acetic acid medium at an analytical wavelength of 410 nm. The calculation of the content of biologically active substances was performed by the standard method, which was used as a rutin. Validation parameters such as specificity, linearity, and precision have been studied for methods for quantifying the sum of substances of flavonoid structure and essential oils.

Conclusions. Available and validated methods for the quantitative determination of the amount of biologically active substances of a dry multicomponent herbal extract in solid capsules have been developed and validated. The studied validation parameters meet the eligibility criteria

Author Biographies

Oleksandr Shmalko, National University of Pharmacy Pushkivska str., 53, Kharkiv, Ukraine, 61002

Department of drug technology

Nataliia Bevz, National University of Pharmacy Pushkivska str., 53, Kharkiv, Ukraine, 61002

PhD, Associate Professor

Department of Pharmaceutical Chemistry

Igor Vyshnevskyy, Farmatsevtycheskaya Fabryka, Ooo Dkp Koroleva str., 4, Stanishivka, Zhytomyr Region, 12430

PhD, general director

Liliia Vyshnevska, National University of Pharmacy, Pushkivska str., 53, Kharkiv, Ukraine, 61002

Doctor of Pharmaceutical Sciences, Professor

Department of drug technology

References

  1. Kucherenko, N., Gudzenko, A. (2017). The analysis of Ukrainian pharmaceutical market in the aspect of solid oral drugs with postponed action. ScienceRise: Pharmaceutical Science, 3 (7), 6–10. doi: http://doi.org/10.15587/2519-4852.2017.103327
  2. Brown, A. C. (2017). An overview of herb and dietary supplement efficacy, safety and government regulations in the United States with suggested improvements. Part 1 of 5 series. Food and Chemical Toxicology, 107, 449–471. doi: http://doi.org/10.1016/j.fct.2016.11.001
  3. Vinnikova, I. I., Ponomarenko, I. V., Hrebnov, H. M. (2015). Vplyv polityko-pravovoho faktoru na reklamu likarskykh zasobiv. Ekonomichnyi visnyk NTUU "KPI", 12, 339–345.
  4. Nemchenko, A. S., Mishchenko, V. I., Timofeiev, S. V., Vynnyk, O. V. (2017). Doslidzhennia vlastyvostei diietychnykh dobavok, likarskykh zasobiv ta kharchovykh dobavok v «piramidi zdorovia liudyny». Menedzhment ta marketynh u skladi suchasnoi ekonomiky, nauky, osvity, praktyky. Kharkiv, 380–381.
  5. Pro udoskonalennia orhanizatsii likuvalnoho kharchuvannia ta roboty diietolohichnoi systemy v Ukraini (2013). Nakaz MOZ Ukrainy No. 931. 29.10.2013. Available at: https://zakon.rada.gov.ua/laws/show/z2205-13
  6. Pro likarski zasoby (1996). Zakon Ukrainy No. 123/96-VR. 04.04.1996. Available at: http://zakon.rada.gov.ua/laws/main/123/96-%D0%B2%D1%80
  7. Pro zatverdzhennia Poriadku derzhavnoi reiestratsii (perereiestratsii) likarskykh zasobiv i rozmiriv zboru za yikh derzhavnu reiestratsiiu (perereiestratsiiu) (2005). Postanova Kabinetu Ministriv Ukrainy No. 376. 26.05.2005. Available at: http://zakon.rada.gov.ua/laws/show/376-2005-%D0%BF
  8. Hubin, Yu. I. (2019). Problemy yakosti diietychnykh dobavok. Upravlinnia yakistiu v farmatsii. Kharkiv: NFaU, 29–31.
  9. Derzhavna Farmakopeia Ukrainy. Vol. 1 (2015). Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 1128.
  10. Derzhavna Farmakopeia Ukrainy. Vol. 3 (2014). Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 732.
  11. Kryzhanovska, A. V., Oproshanska, T. V. (2019). Kontrol yakosti diietychnykh dobavok. Upravlinnia yakistiu v farmatsii. Kharkiv: NFaU, 74.
  12. Suprun, E. V. (2018). Lekarstva i biologicheski aktivnye dobavki: sovremennii vzgliad na ocenku sootnosheniia effektivnost/bezopasnost. Zdorov’ia Ukraini 21 storіchchia, 3 (424). Available at: https://fp.com.ua/articles/lekarstva-y-byologychesky-aktyvnye-dobavky-sovremennyj-vzglyad-na-otsenku-sootnoshenyya-effektyvnost-bezopasnost/
  13. Ostanina, N. V., Kuznetsova, O. M. (2013). Stvorennia dodatkovoho rozdilu «Diietychni dobavky» Derzhavnoi farmakopei Ukrainy – shliakh do zabezpechennia naselennia ukrainy yakisnoiu produktsiieiu. Farmatsevtychnyi zhurnal, 1, 16–20.
  14. Pro zatverdzhennia Kontseptsii rozvytku farmatsevtychnoho sektoru haluzi okhorony zdorovia Ukrainy na 2011–2020 roky (2010). MOZ Ukrainy No. 769. 13.09.2010. Available at: https://zakon.rada.gov.ua/rada/show/v0769282-10
  15. Grizodub, A. I. (2014). Standartizovannye procedury validacii metodik kontrolia kachestva LS. Farmaciia Kazakhstana, 12, 18–25.
  16. Assuring the quality of test results. ORA LABORATORY PROCEDURE. Food and Drug Administration. Document No ORA – LAB 5.9. Available at: https://www.fda.gov/downloads/scienceresearch/fieldscience/laboratorymanual/ucm092168.pdf
  17. Pro zatverdzhennia Derzhavnykh hihiienichnykh pravyl i norm "Rehlament maksymalnykh rivniv okremykh zabrudniuiuchykh rechovyn u kharchovykh produktakh" (2013). Nakaz MOZ Ukrainy No. 368. 13.05.2013. Available at: https://zakon.rada.gov.ua/laws/show/z0774-13
  18. ICH Harmonized Tripartite Guideline: Q3A (R2) Impurities in new substances (2016). The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH), 15.
  19. ICH Harmonized Tripartite Guideline: Q3B (R2) Impurities in new drug products (2006). The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH), 14.
  20. Bevz, N., Georgiyants, V., Gryzodub, O. (2019). Algorithm for carrying out a procedure for verification of a spectrophotometric method for analysis of solid-dosed dosage forms according to the requirements of SPHU 2.0. ScienceRise: Pharmaceutical Science, 3 (19), 4–10. doi: http://doi.org/10.15587/2519-4852.2019.172046
  21. Malinina, N., Yevtushenko, O. (2017). The Order of Circulation of Dietary Supplements that Contain Food Additives on Ukrainian Pharmaceutical Market. Path of Science, 3 (5), 4.1–4.6. doi: http://doi.org/10.22178/pos.22-4
  22. Corby-Edwards, A. K. (2013). Regulation of Dietary Supplements. Congressional Research Service, 29. Available at: https://www.everycrsreport.com/files/20130506_R43062_114049f4d7a3ff8b80d37cffd2f432b95cad17a9.pdf
  23. Yavorski, T., Tomashyk, M., Borkovski, L. et. al. (2016). Zvit shchodo vidpovidnosti protsedury derzhavnoi reiestratsii likarskykh zasobiv v Ukraini zakonodavstvu ta standartam YeS. Available at: https://moz.gov.ua/uploads/0/350-ebrd_project_final_report_ukr_2016_11_30.pdf
  24. Tymchenko, O. V., Kotov, A. H. (2018). Ohliad zakonodavchykh zmin u sferi zabezpechennia yakosti diietychnykh dobavok v Ukraini. Farmakom, 4, 15–24.

Downloads

Published

2019-12-30

How to Cite

Shmalko, O., Bevz, N., Vyshnevskyy, I., & Vyshnevska, L. (2019). Experimental research on development and validation of methods of quantitative determination of flavonoids and essential oil in solid multi-component capsules "Uroholum". ScienceRise: Pharmaceutical Science, (6 (22), 43–49. https://doi.org/10.15587/2519-4852.2019.190552

Issue

Section

Pharmaceutical Science