Introduction. Quinazoline derivatives have a wide range of pharmacological properties, which makes this group quite unique among other classes of heterocyclic compounds. Substance VMA-10-18, which has cerebrovasodilating, antidepressant, anxiolytic and nootropic properties, may become a promising new drug. In this regard, an urgent task is to develop methods for standardizing this substance.Aim. Development of a method for the quantitation of related impurities of a new biologically active substance VMA-10-18 (Quinazophene) by HPLC with subsequent statistical processing of the results.Materials and methods. To develop the conditions for chromatographic analysis, was used a highly purified substance 3-[2-(4-methoxyphenylamino)-2-oxoethyl]-quinazolin-4(3H)-one, as well as its related impurities: impurity I (unsubstituted quinazolin-4(3H)-one) and impurity II (4-methoxychloroacetanilide). Test solutions were prepared using volumetric glassware of accuracy class 1. Ethyl alcohol 95 % was used as a solvent. Chromatography was performed using a Dionex UltiMate 3000 system (Dionex, United States) with a spectrophotometric detector. The analysis was carried out at a wavelength of 231 nm. Data collection and processing was carried out using the Chromeleon v.7 system. A mixture of acetonitrile and orthophosphoric acid was used as a mobile phase. The analysis was performed in an isocratic mode. The validation of the developed method was carried out taking into account the requirements of the State Pharmacopeia of Russian Federation XIV edition and the recommendations of the ICH.Results and discussion. The optimal conditions for chromatography of the VMA-10-18 substance and its impurities have been developed. It was found that for a clear separation of the peaks of the substance and impurities among themselves, the mobile phase should contain acetonitrile and orthophosphoric acid in a ratio of 80 : 20. The specificity of the method was determined by chromatography of ethyl alcohol in order to exclude its influence on the analysis results. The linearity and correctness of the method were determined at 7 levels of concentration of impurities of the substance. The correlation coefficient has exceeded 0.99. Also, the free term of the linear dependence equation (a) for both impurities was less than its confidence interval (Δа), which proves the absence of a systematic error of the method. When determining the "Convergence" indicator, the calculated relative standard deviation did not exceed 2 %. When determining the intralaboratory precision, Student's t-test and Fisher's F-test were calculated. Both indicators met the stated requirements.Conclusion. A method for the quantitative determination of impurities in the VMA-10-18 substance by HPLC has been developed and validated.

Introduction. The aim idea of this research article is a development of the quantitative determination of a biologically active substance quinazolin4(3H)-on derivate with laboratory cypher «VMA-10-182, by UV-spectrophotometry with followed validation. The substance is an effective remedy that combines several pharmacological effects, like an antidepressant, anxiolytic and nootropic. As a result of preclinical trials, the research compound has proven to be an effective remedy in the fight and prevention of acute cerebrovascular accident (stroke). The substance realized pharmacological effects by stimulating the production of nitric oxide by the endothelial cells of the brain. As aresult of stimulating is a vasodilation of the vessels and improvement of blood flow in the ischemic part of the vessels occur. Therefore, for introducing the biologically active substance into medical practice we need to develop ways to control the quality of substance.Aim. The objective of this research work is to develop a method of the quantitative determination of a biologically active substance, derivative quinazolin-4(3H)-on (laboratory sypher – VMA-10-18), by method of UV spectrophotometry. The results of the research work were validated.Materials and methods. In this research we used a substance VMA-10-18 wich was previously purified from the initial and intermediate products of the synthesis. This substance is a white crystalline powder, odorless, hygroscopic.Results and discussion. The quantitative content of the active substance derived quinazolin-4(3H)-on has been determined. The specific absorption rate was calculated, followed by statistical processing of the results. The validation was carried out according to the «Specificity», «Linearity», «Accuracy», «Repeatability». The results indicate the effectiveness of the developed methodology and experimental reproducibility.Conclusion. Researches of physicochemical properties show al us use 95 % ethanol as a solvent. As a result we developed a method for the quantitative determination of the substance which can be proposed for inclusion in the normative documents. The quantitative determination of the active substance in the test substance was established, and the specific absorption index was calculated. All information are statistically processed and meet the requirements of regulatory documentation.

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