Application of the gas chromatography-mass spectrometry method for the identification of standard samples of ACE inhibitors drugs


D.A. Chepilo(1), V.I. Gegechkori(1), 3, O.Yu. Shchepochkina(1), N.N. Chadova(2), A.A. Levko(2), V.N. Shestakov(2)
1-Sechenov First Moscow State Medical University (Sechenov University), Vernadsky ave. 96, building. 1, Moscow, 119571, Russian Federation;
2-Peoples' Friendship University of Russia, Miklukho-Maklaya str. 6, Moscow, 117198, Russian Federation;
3-State Institute of Drugs and Good Practices and Good Practices, 6/1 Lavrov lane, Moscow, 109044, Russian Federation

Introduction. To date, quality control and standardization of drugs, including medicines from the group of angiotensin-converting enzyme inhibitors (ACE inhibitors), as a rule, involves the use of reference standards (RS). In the process of RS development, a number of comprehensive tests are carried out in compliance with the requirements governing the quality of standards. One of the key values of RS quality is the definition of authenticity. Objective: to study the possibility of using the chromatography-mass spectrometric method to determine the identity of RS of antihypertensive medicines of the ACE inhibitor group. Material and methods. As part of the development of RS, the investigated samples of Captopril and Enalapril maleate substances were used. Chromatography-mass spectra of solutions of the studied samples were recorded on a Zhimadzu Nexera liquid chromatograph with a Shimadzu LCMS-8050 mass-selective detector using the following types of ionization – APCI and HESI. Results. The reliability, high sensitivity, accuracy, the informational content of the mass spectrometric method is shown on the example of the identification of the developed RS of Captopril and Enalapril maleate. The determination of the molecular ion and the study of the fragmentation scheme of the main molecular ions in the mass spectra allows us to successfully identify the studied samples of Captopril and Enalapril maleate. Conclusion. Experimental data obtained during the study of samples of Captopril and Enalapril maleate can be used both in quality control of the corresponding RS and in the pharmaceutical analysis of medicinal products containing the same pharmaceutical substances.

ACE inhibitor
reference standard
chromato-mass spectrometry

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