The study of the stability of silver proteinate solutions prepared in pharmacies

Valeriia Cherniakova; Nataliia Bevz; Oksana Strilets; Nataliia Harna; Olena Bevz; Olga Yevtifieieva

doi:10.15587/2519-4852.2023.289798

Authors

Valeriia Cherniakova National University of Pharmacy, Ukraine https://orcid.org/0009-0001-4325-1454
Nataliia Bevz National University of Pharmacy, Ukraine http://orcid.org/0000-0002-7259-8908
Oksana Strilets National University of Pharmacy, Ukraine https://orcid.org/0000-0003-0846-8663
Nataliia Harna National University of Pharmacy, Ukraine https://orcid.org/0000-0003-2918-4985
Olena Bevz National University of Pharmacy, Ukraine https://orcid.org/0000-0002-7695-3612
Olga Yevtifieieva National University of Pharmacy, Ukraine https://orcid.org/0000-0002-0322-7054

DOI:

https://doi.org/10.15587/2519-4852.2023.289798

Keywords:

extemporaneous dosage forms, titrimetric method of analysis, validation, silver proteinate, chemical stability, microbiological purity

Abstract

Today, medicines made in pharmacies are increasingly attracting consumers' attention and are in growing demand in Ukraine. Pharmacy production faces a number of problems, including the study of the stability of extemporaneous dosage forms and the determination of an optimal shelf life. 1 % and 2 % water silver proteinate solutions used in ophthalmology, otolaryngology and nephrology are produced in Ukrainian pharmacies both extemporaneously and as a reserve.

The aim. The aim of the work is to develop methods for quality support and study the chemical stability of 1 % and 2 % water solutions of silver proteinate, and to study the microbiological purity to extend the storage time of nasal drops.

Materials and methods. A study of the chemical stability of 1 % and 2 % water silver proteinate solutions of pharmaceutical production is carried out using chemical identification reactions (to silver and protein), quantitative determination by thiocyanatometric titrimetric method and determination of microbiological purity.

Results. The validation characteristics of the method for the quantitative thiocyanatometric determination of silver proteinate were studied (the correlation coefficient r = 0.9995 and 0.9996; the systematic error – 0.26 % and 0.03 %, the relative confidence interval – 0.88 % and 0.74 % for 1 % and 2 % solutions, respectively), as well as its suitability for this purpose was proven. “Silver proteinate solution, 1.0 %” and “Silver proteinate solution, 2.0 %” prepared in the pharmacy were studied for 150 days by the “Microbiological purity” indicator and were biologically stable.

Conclusions. The chemical identification reactions and methods for the quantitative determination of silver proteinate in an extemporaneous dosage form used to study the chemical stability of the drug have been proposed. The study results of the chemical stability and microbiological purity allow us to recommend pharmacies to extend the shelf life of nasal drops containing silver proteinate as an active pharmaceutical ingredient for 150 days

Author Biographies

Valeriia Cherniakova, National University of Pharmacy

Postgraduate Student

Department of Pharmaceutical Chemistry

Nataliia Bevz, National University of Pharmacy

PhD, Associate Professor

Department of Pharmaceutical Chemistry

Oksana Strilets, National University of Pharmacy

Doctor of Pharmacy, Professor

Department of Biotechnology

Nataliia Harna, National University of Pharmacy

PhD, Associate Professor

Department of Pharmaceutical Chemistry

Olena Bevz, National University of Pharmacy

PhD, Assistant

Department of Medical Chemistry

Olga Yevtifieieva, National University of Pharmacy

Doctor of Pharmacy, Professor

Department of Pharmaceutical Chemistry

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