DEVELOPMENT OF A METHOD FOR CONFIRMING THE AUTHENTICITY OF A PHARMACEUTICAL SUBSTANCE BASED ON THE DERIVATIVE OF 3,7-DIAZABICYCLO[3.3.1]NONANE BY NMR SPECTROSCOPY
Objective. Development of a method for confirming the authenticity of the pharmaceutical substance based on the derivative of 3,7-diazabicyclo[3.3.1]nonane by NMR spectroscopy independently of a standard sample for its further use in pharmaceutical analysis. Materials and methods. The object of the study is a pharmaceutical substance with the chemical name IUPAC 6-[4-methoxy-3-(1H-pyrazole-1-ylmethyl) benzyl]-1,11-dimethyl-3,6,9-triazatricyclo [7.3.1.1] tetradecane-4,8,12-trione, based on the derivative of 3,7-diazabicyclo[3.3.1]nonane. The 1H NMR spectrum of the standard and sample solutions were recorded on a Bruker DPX-400 spectrometer, Germany, with an operating frequency of 400 MHz at a temperature of 28°C. The chemical shifts of the protons were measured in millionths of δн (m.d.) with respect to the residual amount of the solvent 1H of the solvent - deuterochloroform. The concentration in the deuterol-solvent was 5 mg/ml. Results. Based on a comprehensive analysis of NMR spectral data, a method was developed for determining the authenticity of the pharmaceutical substance in encapsulated dosage form, using the method of 1H NMR spectroscopy with documentary confirmation of the suitability of this technique. Conclusion. This technique can be used to determine the authenticity of the pharmaceutical substance based on the derivative of 3,7-diazabicyclo[3.3.1]nonane both separately and as part of the dosage form.