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Registration Number

0222U003642, 0116U005350 , R & D reports

Title

The application of physical and chemical methods in analysis of drugs, which containamino group, phenolhydroxyl in their structure, and others

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Head

Васюк Світлана Олександрівна,

Registration Date

11-05-2022

Organization

Zaporizhzhya State Medical University

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 The work is devoted to the development of highly sensitive, easy to perform, validated spectrophotometric methods for quantitative determination of nitrogen-containing medicinal products on the basis of reactions with quinone derivatives and drugs, containing the secondary aliphatic amino group, using sulphophthalein dies as reagents. There were studied optimal conditions of the photometric reactions of investigational medicinal substances and sulphophthalein dies, quinone derivatives. Lows of identification limitsand ups of molar absorption coefficientstestified the reactions high sensitivity. Defined stoichiometric ratio «reagent – drug substance» by molar ratio and isomolar series method. Stoichiometric coefficients between reagents and drug substances were 1:1 in each case (atenolol, bisoprolol fumarate, betaxolol hydrochloride, carvedilol, metoprolol tartrate, nebivolol hydrochloride, sotalol hydrochloride withsulphophthalein dies and acetylcysteine with 2,3-dichloro-1,4-naphthoquinone, meldonium dehydrate with p-chloranil). Reaction products were isolated and identified. Spectrophotometric methods for the quantitative determination of 15 drugscontaining the secondary aliphatic amino group consisting of 50 commercial agentswere developed and validated. Proved that for such validation characteristics, developed methods of quantitative determination of studied drugs arecorrespondedto The Ukrainian Pharmacopoeia specification. Developed methods can be used in the laboratory of technical control department ofdrugs manufacturersand inspections of drugs quality control.

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Buhaiova Vladlena Volodymyrivna
Donchenko Anastasiia Oleksandrivna
Dochynets Dmytro Ivanovych
Zhuk Yulia Micolaivna
Korzhova Alla Stanislavivna
Miedviedieva Kateryna Pavlivna
Maletska Olena Romanivna
Nahorna Nataliia Oleksandrivna