Development of succinic acid quantitative determination method in the substance of the original compound with antiarrhythmic activity ALM-802S by HPLC
- Authors: Kuznetsov D.N.1, Grushevskaya L.N.1, Sergeeva М.S.1, Gaevaya L.М.1, Denisenko Е.D.1, Dorofeev V.L.1
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Affiliations:
- Federal Research Center for Innovator and Emerging Biomedical and Pharmaceutical Technologies
- Issue: Vol 28, No 6 (2025)
- Pages: 87-98
- Section: Pharmaceutical chemistry
- URL: https://journals.eco-vector.com/1560-9596/article/view/685720
- DOI: https://doi.org/10.29296/25877313-2025-06-12
- ID: 685720
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Abstract
Introduction. N1-(2,3,4-trimethoxybenzyl)-N2-{2-[(2,3,4-trimethoxybenzyl)amino]ethyl}-1,2-ethanediamine succinate, ALM-802S, is a new pharmacologically active compound synthesized at the Federal State Budgetary Scientific Institution «Federal Research Center for Innovator and Emerging Biomedical and Pharmaceutical Technologies» as a result of research aimed at screening and creating original medicines with anti-ischemic and antiarrhythmic 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 chromatographic 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 chromatographic 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.
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About the authors
D. N. Kuznetsov
Federal Research Center for Innovator and Emerging Biomedical and Pharmaceutical Technologies
Author for correspondence.
Email: kuznetsov_dn@academpharm.ru
ORCID iD: 0000-0002-0056-4303
SPIN-code: 6154-6935
Ph.D. (Chem.), Associate Professor, Senior Researcher, Laboratory of Standardization and Quality Control of Medicines, Department of Quality and Technology of Medicines
Russian Federation, Baltiyskaya st., 8, 125315, MoscowL. N. Grushevskaya
Federal Research Center for Innovator and Emerging Biomedical and Pharmaceutical Technologies
Email: grushevskaya_ln@academpharm.ru
ORCID iD: 0000-0002-3794-9661
SPIN-code: 5599-6685
Dr.Sc. (Pharm.), Head of Laboratory of Standardization and Quality Controlof Medicines, Department of Quality and Technology of Medicines
Russian Federation, Baltiyskaya st., 8, 125315, MoscowМ. S. Sergeeva
Federal Research Center for Innovator and Emerging Biomedical and Pharmaceutical Technologies
Email: sergeeva_ms@academpharm.ru
ORCID iD: 0000-0002-7155-6714
SPIN-code: 5017-2424
Ph.D. (Pharm.), Leading Researcher, Laboratory of Standardization and Quality Control of Medicines, Department of Quality and Technology of Medicines
Russian Federation, Baltiyskaya st., 8, 125315, MoscowL. М. Gaevaya
Federal Research Center for Innovator and Emerging Biomedical and Pharmaceutical Technologies
Email: gaevaya_lm@academpharm.ru
ORCID iD: 0000-0002-0083-6030
SPIN-code: 7181-6994
Dr.Sc. (Pharm.), Leading Researcher, Laboratory of Standardization and Quality Control of Medicines, Department of Quality and Technology of Medicines
Russian Federation, Baltiyskaya st., 8, 125315, MoscowЕ. D. Denisenko
Federal Research Center for Innovator and Emerging Biomedical and Pharmaceutical Technologies
Email: denisenko_ed@academpharm.ru
ORCID iD: 0000-0002-0185-9672
SPIN-code: 9184-1348
Junior Researcher, Laboratory of Standardization and Quality Control of Medicines, Department of Quality and Technology of Medicines
Russian Federation, Baltiyskaya st., 8, 125315, MoscowV. L. Dorofeev
Federal Research Center for Innovator and Emerging Biomedical and Pharmaceutical Technologies
Email: dorofeev_vl@academpharm.ru
ORCID iD: 0000-0001-7979-8235
Dr.Sc. (Pharm.), Professor, Acting General Director
Russian Federation, Baltiyskaya st., 8, 125315, MoscowReferences
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