DEVELOPMENT OF SUCCINIC ACID QUANTITATIVE DETERMINATION METHOD IN THE SUBSTANCE OF THE ORIGINAL COMPOUND WITH ANTIARRHYTHMIC ACTIVITY ALM-802S BY HPLC

Introduction. N1-(2,3,4-trimethoxybenzyl)-N2-{2-[(2,3,4-trimethoxybenzyl)amino]ethyl}-1,2-ethanediamine succinate, ALM-802S, is a new pharmaco-logically active compound synthesized at the Federal State Budgetary Scientific Institution «Federal Research Center for Innovator and Emerging Bio-medical and Pharmaceutical Technologies» as a result of research aimed at screening and creating original medicines with anti-ischemic and anti-arrhythmic activity. As part of the research on standardization of the substance ALM-802S, it was decided to specify the content of succinic acid anion in it. The aim of the work is to develop and validate an analytical procedure for the quantitative determination of succinic acid in the substance of a new compound with antiarrhythmic activity ALM–802S. Materials and methods. The objects of the study are an experimental sample of the substance ALM–802S and a by-product of its synthesis N1-(2-aminoethyl)-N2-(2,3,4-trimethoxybenzyl)ethane-1,2-diamine trichloride (ALM-848), as well as a sample of the starting material – 2,3,4-trimethoxybenzaldehyde and a sample of succinic acid.. UV spectra of the studied substances were recorded on a Unico 2804 spectrophotometer (United Products and Instruments, USA), measurements were performed in 10 mm quartz cells of the Hellma Analytics (QS) brand. Chromatographic analysis was performed by high performance liquid chromatography on LC-20 Prominence (Shimadzu, Japan) and Infinity 1260 (Agilent Technologies, USA) liquid chromatographs with gradient pumps and variable wavelength spectrophotometric detectors using a Zorbax SB-C18 StableBond chromato-graphic column in a gradient elution mode. Results. A procedure for the quantitative determination of succinic acid in the substance of a new compound with antiarrhythmic activity ALM-802S has been developed. The validation of the developed procedure was carried out, the linearity and analytical range of the procedure were determined, the accuracy and precision (repeatability, intermediate precision) of the results were confirmed. The parameters and acceptance criteria for chromato-graphic system suitability test have been determined. Conclusions. Using the developed procedure, it was shown that the succinic acid content in the substance ALM-802S corresponds to the theoretical value calculated based on the structural formula of the compound.