Greening of the method for simultaneous determining the enisamium iodide and tilorone dihydrochloride using GC-FID assay

Anastasiia Belikova; Liudas Ivanauskas; Lyudmila Sidorenko; Vasyl Chorny; Anna Kononenko; Alla Koval; Victoriya Georgiyants

doi:10.15587/2519-4852.2023.295120

Authors

Anastasiia Belikova National University of Pharmacy, Ukraine https://orcid.org/0000-0002-1716-6029
Liudas Ivanauskas Lithuanian University of Health Sciences, Lithuania https://orcid.org/0000-0001-5390-2161
Lyudmila Sidorenko National University of Pharmacy, Ukraine https://orcid.org/0000-0001-8431-8398
Vasyl Chorny Farmak JSC; National University of Pharmacy, Ukraine https://orcid.org/0000-0002-5417-9881
Anna Kononenko National University of Pharmacy, Ukraine https://orcid.org/0000-0003-0845-9353
Alla Koval National University of Pharmacy, Ukraine http://orcid.org/0000-0001-9491-0459
Victoriya Georgiyants National University of Pharmacy, Ukraine https://orcid.org/0000-0001-8794-8010

DOI:

https://doi.org/10.15587/2519-4852.2023.295120

Keywords:

Enisamium iodide, Tilorone dihydrochloride, GC-FID, method development, validation, “green” analytical analysis, pharmaceutical wastes

Abstract

Pharmaceutical companies in Ukraine aspire to develop their innovative medicinal products and successfully introduce them to the global market. However, along with the prospects of increased usage of these pharmaceuticals, there arises a challenge of heightened waste production, making them a part of the over twenty million tons of PPCPs produced annually. Consequently, one of the tasks in producing new pharmaceuticals is the development of methodologies and approaches not only for quality control but also for their determination in the environment matrices.

The aim. Develop and validate GC-FID chromatographic method for the simultaneous determination of Enisamium iodide and Tilorone dihydrochloride, evaluate their applicability, and compare their "greenness" with the previously developed HPLC method.

Materials and methods. The determination of the Tilorone dihydrochloride and Enisamium iodide was carried out by gas chromatography with a flame ionization detector using the Rxi-5 ms (30 m long, 0.25 mm outer diameter and 0.25 μm liquid stationary phase thickness)

Results. Chromatographic GC-FID methods have been developed for the simultaneous determination of Enisamium iodide and Tilorone dihydrochloride. Optimal sample preparation conditions were established, and a validation process was conducted. A comparison with the previously developed HPLC method was made regarding "greenness."

Conclusions. The developed GC-FID methodology is accurate and more environmentally friendly compared to the previously established methods. It can be recommended to determine Enisamium iodide and Tilorone dihydrochloride in the environmental matrices. It is considered environmentally friendly based on the overall GREENness (AGREE) scale, scoring 0.73 (>0.70), which demonstrates the environmentally favourable nature of the proposed analytical approach

Author Biographies

Anastasiia Belikova, National University of Pharmacy

Postgraduate Student

Department of Pharmaceutical Chemistry

Liudas Ivanauskas, Lithuanian University of Health Sciences

Professor, Head of Department

Department of Analytical and Toxicological Chemistry

Lyudmila Sidorenko, National University of Pharmacy

Doctor of Pharmaceutical Sciences, Professor

Department of Pharmaceutical Chemistry

Vasyl Chorny, Farmak JSC; National University of Pharmacy

PhD, Head of Laboratory

Senior Researcher

Anna Kononenko, National University of Pharmacy

PhD, Assistant

Department of Pharmacology and Pharmacotherapy

Alla Koval, National University of Pharmacy

PhD, Associate Professor

Department of General Chemistry

Victoriya Georgiyants, National University of Pharmacy

Doctor of Pharmaceutical Sciences, Professor, Head of Department

Department of Pharmaceutical Chemistry

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