Development of a quantitative determination method of a new quinozalinino derivative 2-benzoilamino-n-[4-(4,6-dimethylpyrimidin- 2-ilsulfamoil)-phenyl]-benzamide method of non-water titration

In the course of preclinical testing of the substance, research is needed aimed at developing methods of analysis, standardization and the creation of a regulatory document - a pharmacopeia article (FS). To assess the quality of pharmaceutical substances, various quantitative methods are used (titrimetric, chromatographic, spectral). Many methods use standard samples, which are very difficult to obtain when developing methods of a new biologically active substance. The titrimetric methods of pharmaceutical analysis are quite accurate, affordable, simple and do not require complex and expensive equipment and reagents. The purpose of this study is the development and validation of a method for the quantitative determination of the investigated substance - 2-benzoylamino-N- [4-(4,6-dimethylpyrimidin-2-ylsulfamoyl) phenyl] benzamide. During pharmacological studies, anxiolytic, actoprotective and antidepressant activities were established for this compound. Material and methods. The objects of study were the studied samples of the substance 2-benzoylamino-N-[4-(4,6-dimethylpyrimidin-2-ylsulfamoyl) phenyl] benzamide synthesized at the Department of Organic Chemistry of the Pyatigorsk Medical and Pharmaceutical Institute. Results. The results of the developed procedure for the quantitative determination by a non-aqueous titration method of a new quinosalinone derivative of 2-benzoylamino-N-[4-(4,6-dimethylpyrimidin-2-ylsulfamoyl) phenyl] benzamide are presented. It has been shown that the solvent system is the most protogenic medium for the substance under study. glacial acetic acid - formic acid 10:10 ml. When developing the method using the crystalline violet indicator, the average content of the test substance is 97.12%, the relative error is 2.21%. The potentiometric determination of the end point of the titration showed that the average content of the test substance is 98.67%, the relative error is 1.57%. Conclusion. Thus, we have developed a method for the quantitative determination of a new quinosalinone derivative with pharmacological activity - 2-benzoylamino-N- [4- (4,6-dimethylpyrimidin-2-ylsulfamoyl) phenyl] benzamide. The end point of the titration is determined along with the classic indicator crystal violet, it is proposed to carry out using the potentiometric method. A validation assessment of the developed methodology was carried out according to the indicators: linearity, convergence and correctness.

non-aqueous titration, potentiometry, crystalline violet, glacial acetic acid, chinozalinones