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.
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