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DEVELOPMENT AND VALIDATION OF THE QUANTITATIVE DETERMINATION METHOD FOR A NEW BIOLOGICALLY ACTIVE COMPOUND N-[2-[4-OXO-3(4Н)-QINAZOLINYL]PROPIONYL]-GUANIDINE BY THE METHOD OF TITRATION IN A NON-AQUEOUS MEDIUM

DOI: https://doi.org/10.29296/25877313-2023-09-05
Issue: 
9
Year: 
2023

D.N. Lutsenko
Specialist in Educational and Methodological Work, Department of Biological Chemistry,
Pyatigorsk Medical and Pharmaceutical Institute – Branch of the State Budgetary Educational Institution of Higher Education
"Volgograd State Medical University" of the Ministry of Health of the Russia (Pyatigorsk, Russia)
E-mail: lucenkodasha95@mail.ru
E.V. Kompantseva
Dr.Sc. (Pharm.), Professor, Department of Pharmaceutical Chemistry,
Pyatigorsk Medical and Pharmaceutical Institute – a Branch of the State Budgetary Educational Institution
of Higher Education "Volgograd State Medical University" of the Ministry of Health of the Russia (Pyatigorsk, Russia)
E-mail: dskompanceva@mail.ru
A.S. Chiriapkin
Lecturer, Department of Pharmaceutical Chemistry, Pyatigorsk Medical and Pharmaceutical Institute –
Branch of the State Budgetary Educational Institution of Higher Education "Volgograd State Medical University"
of the Ministry of Health of the Russia (Pyatigorsk, Russia)
E-mail: alexey.chiriapkin@yandex.ru -mail,
L.S. Ushakova
Ph.D.(Pharm.), Associate Professor, Department of Toxicological and Analytical Chemistry,
Pyatigorsk Medical and Pharmaceutical Institute – a Branch of the State Budgetary Educational Institution
of Higher Education "Volgograd State Medical University" of the Ministry of Health of the Russia (Pyatigorsk, Russia)
E-mail: uchakova2002@yandex.ru

Relevance. Due to the wide spread of diseases of the cardiovascular system, the development and study of drugs aimed at the treatment of diseases of the circulatory system is relevant. A new biologically active compound (BAC) is synthesized at the Department of Pharmaceutical and Toxicological Chemistry of the Volgograd State Medical University – a derivative of quinazoline: N-[2-[4-oxo-3(4H)-quinazolinyl] propionyl]-guanidine (VMA-13-15), which at the stage of preclinical studies confirmed the prospects for use in medical practice as a cardioprotective and neuroprotective drug. The aim of the study is to develop and validate a method for the quantitative determination of N-[2-[4-oxo-3(4H)-quinazolinyl]propionyl]-guanidine (VMA-13-15). Material and methods. The objects of study are laboratory samples of N-[2-[4-oxo-3(4H)-quinazolinyl]propionyl]-guanidine (VMA-13-15, series 2019, 2020 and 2021). A laboratory sample VMA-13-15 twice recrystallized from methanol and dried to constant weight is used as a standard sample (RS). Quantitative determination is carried out by acid-base titration in a non-aqueous medium. The end of the titration is fixed potentiometrically. Results. The ionization constants VMA-13-15 are determined. A procedure is developed for the quantitative determination of N-[2-[4-oxo-3(4H)-quinazolinyl]propionyl]guanidine by acid-base titration in a solvent medium of glacial acetic acid with the establishment of an equivalence point using a potentiometer. The developed method is validated according to the main characteristics: specificity, linearity, correctness, convergence and analytical area. The validation analysis of the developed method confirms that it is suitable for the quantitative determination of the main substance content in the VMA-13-15 substance. Conclusions. A technique for potentiometric titration of N-[2-[4-oxo-3(4H)-quinazolinyl]propionyl]guanidine in a non-aqueous medium is developed and validated.

Keywords: 
N-[2-[4-oxo-3(4H)-quinazolinyl]propionyl]guanidine
ionization constants
potentiometric determination
validation.

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