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

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.