Pharmacology (medical), Pharmacology, Toxicology and Pharmaceutics, Drug Discovery, Pharmaceutical Science
9
Scopus Publications
Scopus Publications
Comparative study of the efficacy and safety of tirzepatide drugs in metabolic syndrome A. A. Andreev-Andrievsky, V. S. Shcherbakova, S. V. Drugova, M. A. Mashkin, A. A. Narizhnyak, et al. Farmatsiya I Farmakologiya, 2026 In the last decade, developed countries have seen a steady increase in the prevalence of metabolic disorders. The most significant among them are obesity and type 2 diabetes mellitus. Tirzepatide is an innovative drug, representing the first-in-class dual agonist of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. Tirzepatide combines the action of two key incretin hormones, providing more comprehensive and effective regulation of glycemia and metabolism compared to traditional GLP-1 monoagonists. Tirzepatide was unavailable in Russia for a long time. However, in 2025, the first domestically produced tirzepatide drug, Tirzetta® (LLC “PROMMOMED RUS”), appeared. The aim. To conduct a comparative evaluation of the efficacy and safety of the reproduced drug Tirzetta® (INN: Tirzepatide, manufacturer LLC “PROMMOMED RUS”) and the reference drug Mounjaro® (INN: Tirzepatide, manufacturer “Eli Lilly”) in a mouse model with induced metabolic syndrome (MS). Materials and methods. The study was conducted on male mice of the C57BL/6 line. To metabolic syndrome (MS) was induced in animals with a diet high in fat and carbohydrates. Three batches of Tirzetta® and one series of Munjaro® were investigated. The drugs were administered at a dosage of 150 µg/kg subcutaneously once every three days for 15 days. During the experiment, glucose tolerance and insulin sensitivity tests were performed. The type of metabolism was determined by indirect calorimetry data. Mice were euthanized on 25th day for humane reasons upon reaching any of the following criteria: body weight loss of more than 15% in a week; serious injuries (fractures, amputations, etc.), appearance of non-healing wounds; seizures; unconscious state. A complete blood count was performed, and the following parameters were determined: glucose, triglycerides, cholesterol, AST, ALT. Necropsy was performed after euthanasia. During necropsy, the thoracic and abdominal organs of the animals were examined, and organs were dissected and weighed. Results. In the MS group animals, body weight increased to 39.5 ± 0.6 g compared to the control group (31.9 ± 0.6 g), representing a 24% increase. Significant hyperglycemia was recorded with a glucose concentration of 14.9 ± 2.7 mmol/L versus 6.1 ± 0.4 mmol/L in the control, as well as a pronounced decrease in glucose tolerance in the loading test. The investigated tirzepatide drugs demonstrated a pronounced hypophagic effect with a 26–28% reduction in body weight, normalization of glycemia with a 48–53% decrease in glucose concentration, and improvement in glucose tolerance and insulin sensitivity. Indirect calorimetry data indicated a decrease in the respiratory exchange ratio, suggesting lipolysis activation. A significant reduction in triglyceride content in blood serum and liver was revealed. The bioequivalence of the investigated drugs Tirzetta® and Mounjaro® was established in the experimental MS model in mice based on a set of therapeutic efficacy and safety indicators. Conclusion . Studies on an experimental model of induced MS in mice showed equivalent efficacy of Tirzetta® (INN: Tirzepatide, manufacturer LLC “PROMMOMED RUS”, Russia) and Mounjaro® (INN: Tirzepatide, manufacturer “Eli Lilly”, USA).
Study of the efficacy and safety of hexapeptide succinate in hospitalized patients with community-acquired pneumonia: A single-blind, multicenter, randomized, comparative, placebo-controlled study S. N. Avdeev, L. A. Balykova, T. I. Chudinovskikh, N. E. Kostina, N. M. Selezneva, et al. Pulmonologiya, 2025 The search for treatment methods for community-acquired pneumonia (CAP) is currently urgent. Therefore, the search for new therapeutic solutions, including the use of innovative drugs with pronounced anti-inflammatory, antioxidant, and regenerative properties that help prevent lung damage and minimize complications when used as part of combination therapy, is in high demand. The aim of the study was to evaluate the efficacy and safety of tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate (Ambervin® Pulmo (AP), Promomed Rus LLC, Russia) in hospitalized patients with CAP. Methods. The study included 208 patients hospitalized with CAP and randomized into 2 groups. Along with standard therapy, patients in group 1 (n = 104) received tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate by inhalation for 10 days at a dose of 11.6 mg once daily; group 2 (n = 104) received placebo by inhalation once daily. The prescribed therapy was assessed according to primary and secondary efficacy and safety endpoints. Results. Clinical cure by Visit 5 (day 10) was observed in 57 (54.81%) of 104 patients receiving AP (Group 1) and in 35 (36.08%) of 97 patients in the placebo group. The mean time (± SD, per day) to achieving the criteria of clinical stability or discharge from the hospital was 2.54 ± 0.89 days in the AP group and 3.38 ± 1.64 days in the placebo group. Statistically significant advantages of AP over placebo in other secondary endpoints also indicate the high efficacy of the therapy. The analysis demonstrated a favorable safety profile of the study drug. No new data on the safety of AP that would affect the change in its safety profile were identified. Conclusion. In patients receiving tyrosyl-D-alanylglycyl-phenylalanyl-leucyl-arginine succinate, compared to the placebo group, body temperature normalized as early as the third day of therapy, and the symptoms improved, including cough, sputum production, headache, weakness, night sweats, and chills. The use of AP was associated with reduced need for antibacterial medications and lower risk of developing complications of CAP. The results of the clinical trial demonstrated the clinical efficacy and pharmacoeconomic feasibility of hexapeptide succinate therapy.
Evaluation of Physicochemical Properties and Biological Activity of Tirzepatide-Based Drugs P. I. Makarevich, N. A. Alexandrushkina, P. A. Podlesnaya, Yu. G. Kazaishvili, P. A. Belyy, et al. Farmatsiya I Farmakologiya, 2025 Currently, there is a steady increase in the prevalence of metabolic disorders among the population of developed countries. Among them, obesity and type 2 diabetes mellitus are the most important health problems. Tirzepatide is an innovative drug that is a dual agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors. The medcine is effective for the treatment of type 2 diabetes mellitus and obesity. The first drug with the active substance tirzepatide in Russia was Tirzetta® (manufacturer LLC «PROMOMED RUS»), which is the first in Russia, but not in the world. The reference drug for it is Munjaro® (INN: tirzepatide, Eli Lilly and Company, USA). To date, the question of the equivalence of these drugs has not been fully studied. The aim. To conduct a comprehensive comparative evaluation of the reproduced drug Tirzetta® (INN: tirzepatide, manufacturer LLC “PROMOMED RUS”) and the reference drug Munjaro® (INN: tirzepatide, manufacturer Eli Lilly and Company, USA). Materials and methods. The authenticity and quality of drugs were assessed by physicochemical methods according to the current pharmacopoeia of the EAEU. Spectrophotometry in the UV region, HPLC-MS/OF, and gel filtration chromatography were performed. The analysis of agonism to GIP and GLP-1 receptors was performed in vitro using reporter cell lines. The studies were performed in accordance with EMA, FDA, EAEU guidelines and in accordance with the current EAEU pharmacopoeia. Results. As a result of the evaluation of the physicochemical properties of the studied series of Tirzetta® and the reference drug Munjaro®, it was found out that the absorption spectra in the ultraviolet region, the profile of related impurities and their quantitative content, the profile of high-molecular-weight compounds and their quantitative content, as well as mass spectra in all the studied series were similar. During the evaluation of the biological activity of the Tirzetta® and Munjaro® series, results were obtained that demonstrated the absence of statistically significant differences in the ability to activate GLP-1 and GIP receptors ( p <0.0001). Conclusion. During the studies, the equivalence of the physicochemical properties and biological activity of the Russian drug Tirzetta® to the comparator drug Munjaro® was confirmed.
The efficacy of liraglutide-based drugs on the model of induced metabolic syndrome in experimental animals A. A. Andreev-Andrievsky, M. A. Mashkin, M. Vannous, O. V. Fadeeva, Yu. G. Kazaishvili, et al. Farmatsiya I Farmakologiya, 2025 Today, there is an annualincrease in the prevalence of obesityandoverweightworldwide.Thisproblem is becomingparticularlyrelevant,sincetheseconditionsserve as keyriskfactors for the development of anumber of cardiovascularandmetabolicdisorders,including type 2diabetesmellitus(T2DM).On the territory of the Russian Federation, drugswerepresentedasagonists of glucagon-like peptide of the first type (GLP-1)receptors, the activesubstance of which was producedexclusively by biotechnologicalmeans. It is important to notethat solid-phasechemicalsynthesisisalsooneof the alternativemethods for obtainingGLP-1analogues. A significantadvantage of thismethodoverbiotechnologicalsynthesisis the exclusion of spontaneousamino acid substitutionsand the absence of impuritiescharacteristicofthismethod.The aim. Evaluation of the biological activity of the domestic medicinal product liraglutide (Enligria®, solution for subcutaneous administration, 6 mg/ml, PROMOMED RUS LLC), obtained by chemical synthesis, and a foreign reference drug (Saxenda®,solutionforsubcutaneousadministration,6 mg/ml,NovoNordiskA/C),obtainedbiotechnologically.Materials and methods. The effectiveness of liraglutide preparations was evaluated using a model of induced metabolic syndrome in CBA×C57BL/6 SPF mice (n=36,age6months)according to changes in body weight,feedintake,bloodglucoseandlipid levels, and adiposetissuemass.Results. According to the results of the study, it was shown that Enligria® and Saxenda® drugs have comparable efficacy parameters and statistically significantly (p < 0.05) reduce body weight (13.6±2.1% and 13.3±3.3%, respectively), glucose levels (18 ± 3% and 16 ± 9%), triglycerides (32 ± 12% and 40 ± 18 %) and cholesterol (16 ± 7% and 18 ± 9%) in the blood. Enligria® reduced the mass of structural subcutaneous fat by 32 ± 3% (p < 0.0001), and visceral fat by 34 ± 4% (p < 0.0001). The studiedliraglutidepreparationsshowed a pronouncedhypoglycemiceffect,observedinalldoseranges. The observedhypoglycemiceffectwasdose-dependent.Conclusion. The results of the work indicate the high effectiveness of the synthetic drug Enligria®, which is expressed in reducing body weight and improving metabolic parameters.
Molnupiravir in the treatment of patients with influenza or acute respiratory viral infections: a multicenter comparative randomized double-blind placebo-controlled trial O. M. Drapkina, A. Yu. Gorshkov, T I. Chudinovskikh, E. N. Simakina, G. V. Rodoman, et al. Farmatsiya I Farmakologiya, 2025 The aim. To evaluate the efficacy and safety of molnupiravir compared to placebo in patients with influenza and/or ARVI.Materials and methods. The study involved 300 patients. The study included patients aged 18 to 80 years with clinical signs of influenza/ARVI (duration no more than 48 hours): elevated body temperature ≥37.5℃ and the presence of at least 2 symptoms of moderate severity (chills, headache, myalgia, sore throat, nasal congestion, runny nose, sneezing, cough, with laboratory-confirmed diagnosis of influenza/ARVI at the time of screening), meeting the selection criteria for the study. Group 1 (n=150) received the investigational medicine molnupiravir (Esperavir®, Promomed Rus LLC, Russia) 800 mg (4 capsules) 2 times/day (daily dose 1600 mg) for 5 days; Group 2 (n=150) received placebo 4 capsules 2 times/day for 5 days, then patient observation was carried out until day 14 (4 visits after screening). The effectiveness of therapy was assessed according to primary and secondary efficacy criteria. The primary efficacy criterion was the time (in days) to clinical recovery. Safety was assessed by considering the number and severity of adverse events (AEs) and serious adverse events (SAEs). For the analysis of qualitative indicators, an intergroup comparison of proportions was performed using a two-sided version of Fisher's exact test, or the χ2 ("chi-square") test. For quantitative indicators — using the non-parametric Mann-Whitney test. Differences were considered statistically significant at p <0.05.Results. According to the results of the assessment of the primary efficacy criterion, it was shown that molnupiravir therapy statistically significantly reduces the time to clinical recovery compared with placebo (p=0.000039). According to secondary efficacy criteria, a statistically significant advantage of therapy with the investigational medicine compared with placebo was also demonstrated in terms of the frequency of patients who achieved clinical recovery at Visits 2 and 3 p=0.0110, p=0.0070), the frequency of virus elimination. Even on the 3rd day of therapy, the frequency of virus elimination in the investigational drug group was 64.7% compared with 40% in the placebo group (p<0.0001). Statistically significant differences were also shown between the groups in the frequency of patients with the development of ARVI/influenza complications (bronchitis, acute sinusitis, pneumonia, tonsillitis, tracheitis, tracheobronchitis) by Visits 2–4 (Day 3–14) (p<0.0001), which proves the validity of using targeted antiviral therapy in relation to achieving surrogate therapy endpoints. Therapy with the investigational medicine was characterized by a favorable safety profile. The registered AEs in the molnupiravir and placebo groups belong to the category of expected and did not require drug withdrawal. No SAEs were observed during the study.Conclusion. As a result of the phase III clinical study, the efficacy of molnupiravir (Esperavir®, Promomed Rus LLC, Russia) in the treatment of influenza and/or ARVI and the prevention of the risk of developing complications compared with placebo was proven: patients achieved clinical recovery as early as on the 3rd day of therapy. A favorable safety profile was shown, corresponding to the general characteristics of the medicine.
Russian development for drug independence in endocrinology: сomparative analysis of bioequivalence, safety and tolerability of the first domestic liraglutide A. S. Ametov, I. E. Shokhin, E. A. Rogozhina, T. G. Bodrova, M. E. Nevretdinova, et al. Farmatsiya I Farmakologiya, 2023 Liraglutide is one of the analogues of the incretin hormone human glucagon-like peptide-1 (GLP-1) and is currently a priority treatment for diseases such as type 2 diabetes mellitus (mono- and combination therapy), obesity and overweight in the presence of at least one concomitant disease.The aim of the work was to assess the bioequivalence and comparability of the safety and tolerability profile of the drug Enligria® (liraglutide 6 mg/ml, Promomed RUS LLC, Russia) and the drug Saxenda® (liraglutide 6 mg/ml, Novo Nordisk AS, Denmark) after a single dose in healthy volunteers.Materials and methods. This study was an open-label, randomized, crossover comparative study to evaluate pharmacokinetic parameters, safety, tolerability and immunogenicity. The study comprised 26 healthy volunteers, 26 of whom were included in the bioequivalence assessment population. The study consisted of 2 periods, in each of which the volunteers received either the test drug (liraglutide at a single dose of 0.6 mg) or the reference drug (liraglutide at a single dose of 0.6 mg) once. The washout period between each dose was 7 days. Blood plasma samples were taken to determine the concentration of liraglutide in the range from 0 to 72 hours in each study period. Liraglutide concentrations were determined using a previously validated enzyme-linked immunosorbent assay (ELISA) method. A quantitative determination of antibodies to liraglutide in the blood serum samples was carried out using a microplate photometer and ready-made ELISA kits pre-validated by the manufacturer. The conclusion about the equivalence of the compared drugs was made based on the ratio of the parameters Cmax, AUC0→t and AUC0→t of the studied drug in relation to the reference one.Results. The pharmacokinetic parameters of the drugs were comparable to each other. The resulting 90% confidence intervals for the ratio of the values of Cmax, AUC0-t and AUC0-∞ of the Russian test and reference drug were 87.18–110.46, 84.40–104.11 and 86.69–103.22% respectively, which satisfied the criteria for assessing bioequivalence. The tolerability of the drugs in the volunteers was notified as good. The incidence of adverse events was comparable for the test and reference drugs. No serious adverse events were reported throughout the study. According to the results of the immunogenicity analysis, no antibodies to russian produced liraglutide were detected in the blood serum of the volunteers, which indicated the lack of the drug immunogenicity.Conclusion. During the study, the pharmacokinetic equivalence of the test and reference drugs was confirmed. The Russian drug Enligria® (liraglutide 6 mg/ml, Promomed RUS LLC, Russia) in comparison with a foreign drug Saxenda® (liraglutide 6 mg/ml, Novo Nordisk AS, Denmark).
Comparative analysis of physicochemical properties, bioequivalence, safety and tolerability of the first domestic semaglutide A. S. Ametov, I. E. Shokhin, E. A. Rogozhina, T. G. Bodrova, M. E. Nevretdinova, et al. Farmatsiya I Farmakologiya, 2023 Semaglutide is a representative of analogues of the incretin hormone human glucagon-like peptide-1 (GLP-1) and is currently used in Russia for the treatment of type 2 diabetes mellitus (T2DM; in monotherapy and in combination therapy), including patients with obesity and overweight.The aim of the work was to conduct a comparative assessment of the physicochemical properties, a biological activity, bioequivalence and safety, including tolerability and immunogenicity, of the drug Quincent® (semaglutide, 1.34 mg/ml, a solution for a subcutaneous administration, Promomed Rus LLC, Russia) and the drug Ozempic® (semaglutide, 1.34 mg/ml, a solution for a subcutaneous administration, Novo Nordisk A/S, Denmark) when administered to healthy volunteers.Materials and methods. To assess the degree of similarity of the study drug Quincenta® (semaglutide, 1.34 mg/ml, a solution for a subcutaneous administration, Promomed Rus LLC, Russia) with a chemically synthesized active substance to the original (reference) drug Ozempic® (semaglutide, 1.34 mg/ml, a solution for a subcutaneous administration, Novo Nordisk A/S, Denmark), a comparative study of physicochemical properties and a biological activity was carried out. To assess the bioequivalence of the study drug and the reference drug, an open randomized parallel comparative study with the participation of healthy volunteers (n=54), 54 participants of which had been included in the population, was conducted. The volunteers were randomized into 2 groups in a 1:1 ratio, and received a single dose subcutaneously either of the study drug (domestic semaglutide at a dose of 0.5 mg) or the reference drug (foreign semaglutide at a dose of 0.5 mg). The mode of administration was in the morning on an empty stomach. A semaglutide concentration was determined in serum samples using a previously validated enzyme-linked immunosorbent assay (ELISA) method. A quantitative determination of antibodies to semaglutide in the human serum by ELISA was carried out with a microplate photometer using ready-made kits pre-validated by the manufacturer. The conclusion about the bioequivalence of the compared drugs was made using an approach based on the assessment of 90% confidence intervals for the ratios of the geometric mean values of the parameters Cmax, AUC(0–t) of semaglutide in the measurement original units.Results. The results of the comparative analysis of the study drug and the reference drug demonstrate the comparability of their physicochemical properties and biological activity. The results of the clinical study demonstrated the bioequivalence of the test drug and the reference drug. Thus, the pharmacokinetic parameters of the drugs were comparable to each other: the Cmax value for the study drug was 42.088±8.827 ng/ml, for the reference drug Ozempic® it was 42.2556±7.84. Herewith, the half-life for the study drug and the reference drug was 168.39±39.47 and 157.99±28.57 hours, respectively. The resulting 90% confidence intervals for the ratio of the Cmax and AUC0–t values of the study drug and the reference drug were 90.89–109.15 and 91.66–111.27%, respectively. The tolerability of the drugs in the volunteers was notified as good. No adverse events were recorded during the study. No serious adverse events were reported throughout the study. According to the results of the immunogenicity analysis, no antibodies to Russian-made semaglutide were detected in the blood serum of the volunteers, which indicated the lack of Results. The results of a comparative analysis of the study drug and the reference drug demonstrate the comparability of physicochemical properties and biological activity. The results of the clinical study demonstrated the bioequivalence of the study drug and the reference drug. Thus, the pharmacokinetic parameters of the drugs were comparable to each other: the Cmax value for the study drug was 42.088±8.827 ng/ml, for the reference drug Ozempic® this figure was 42.2556±7.84. At the same time, the half-life for the study drug and the reference drug was 168.39±39.47 and 157.99±28.57 hours, respectively. The resulting 90% confidence intervals for the ratio of the Cmax and AUC0–t values of the study drug and the reference drug were 90.89–109.15 and 91.66–111.27%, respectively. Tolerability of the drugs in volunteers was noted as good. No adverse events were recorded during the study. No serious adverse events were reported throughout the study. According to the results of the immunogenicity analysis, no antibodies to Russian-made semaglutide were detected in the blood serum of the volunteers, which indicated the lack of the drug immunogenicity.Conclusion. In the course of the study, the comparability of the physicochemical properties and biological activity of the studied Russian drug with the chemically synthesized active substance Quincenta® to the reference drug Ozempic® was confirmed: the activity range of the studied drugs was within 80–120% in relation to the standard sample of semaglutide. The bioequivalence and a similar safety profile, including the immunogenicity and tolerability of the Russian drug Quincenta® (semaglutide 1.34 mg/ml, Promomed Rus LLC, Russia) were shown in comparison with the foreign drug Ozempic® (semaglutide 1.34 mg/ml, Novo Nordisk A/C, Denmark).
Use of high performance liquid chromatography in the analysis of a new substance vma-10-18 E. S. Mischenko, J. S. Lazaryan, A. Jh. Lazaryan Drug Development and Registration, 2021 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.
Development of uv-spectrophotometry method of the quantitative determination of a new substance quinazoline-4(3h)-on derivate E. S. Mishchenko, A. D. Lazaryan, T. T. Lihota Drug Development and Registration, 2020 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.
