Determination of biologically active compounds N-[2-[4-oxo-3(4H)-qinazolinyl] propionyl]-guanidine by capillary electrophoresis

Currently, the capillary electrophoresis method is one of the most promising and highly effective methods of separation and analysis of medicines, which is very important in pharmaceutical production. The method was first included in the State Pharmacopoeia of Russia in the 13th edition. The purpose of this study was to develop and validate a method for determining the biologically active compound (BAS) N-[2-[4-oxo-3 (4H)-quinazolinyl]propionyl]-guanidine (VMA-13-15) using capillary electrophoresis. Object of research. For analysis, the VMA-13-15 compound obtained in the laboratory was used as an object. As a standard sample (CO), n-[2-[4-oxo-3(4H)-quinazolinyl]propionyl]-guanidine BAS was recrystallized twice from methanol and dried to a constant mass. Results. A method for qualitative and quantitative determination of BAS N-[2-[4-oxo-3(4H)-quinazoline]propionyl]-guanidine by capillary electrophoresis was developed. The proposed method is valid for the following parameters: specificity, linearity, correctness, and precision. The suitability of the chromatographic system is shown. Conclusions. The method of quantitative determination of a new cardioprotective agent can be recommended for inclusion in the draft regulatory documentation for the quantitative determination of N-[2-[4-oxo-3(4H)-quinazolinyl]propionyl] - guanidine, for created medicines based on it, both for oral and parenteral administration, and can also serve as a basis for determining the shelf life of ALS both in the substance and in its medicinal products.

BAS, capillary electrophoresis, validation