Comparative Analysis of Dalargin Pharmaceutical Substance Identification Methods

• Main Authors: M. G. Shulzhenko, I. A. Vasilenko, B. I. Ugrak, I. E. Shohin, Yu. V. Medvedev, E. A. Malashenko
• Format: Article
• Language: Russian
• Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2020-08-01
• Series: Разработка и регистрация лекарственных средств
• Subjects: dalargin; leucine enkephalin; determination of authenticity; mass spectrometry; nmr spectrometry; ir spectrometry
• Online Access: https://www.pharmjournal.ru/jour/article/view/794
• ISSN: 2305-2066; 2658-5049

Introduction. The quality control of a medicinal product needs to be systematically improved in connection with a continuous increase in the requirements for the quality of medicines. When assessing the quality of substances and drugs, the most important indicators are authenticity, the content of the main substance and impurities. This makes it relevant to introduce modern physical and chemical methods of analysis into industrial practice in determining parameters such as authenticity, the content of the main substance and impurities. The choice and applicability of a particular method is possible only when conducting comparative studies on the application of a particular method to solve this problem. The method should preferably be recommended by the Pharmacopoeia, give unambiguous results, and the analysis should not be expensive and affordable. The methods chosen for comparative analysis are well known, but it should be noted that in recent years, instrument-making companies have significantly improved their instrument base and expanded their capabilities. Therefore, one of the objectives of this article is to demonstrate the capabilities of the selected methods for solving the problems of drug quality control using dalargin as an example.Aim. To develop methods for determining the authenticity of the active substance in a substance - Dalargin powder using NMR spectroscopy, IR spectrometry, and Mass spectroscopy. Conduct a comparative analysis of the applicability of the selected methods to solve the problem.Materials and methods. To determine the authenticity of the substance - the powder «Dalargin» used the methods of mass spectrometry, 13C NMR and 1H NMR spectrometry and IR spectrometry.Results and discussions. Methods have been developed for determining the authenticity of the test substance by NMR, IR, and mass spectrometry. A comparative study of the possibilities of the selected methods in solving the problem. Conclusions were drawn about the applicability of the NMR method not only in determining the authenticity of dalargin, but also in solving the problem of determining the content of the main substance and impurities.Conclusion. Authenticity methods have been developed in the substance - Dalargin powder by Mass, IR, and NMR spectrometry. It has been established that 1H NMR spectrometry is a more informative method for authenticating.