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Introduction. Gout treatment drugs are widely represented on the pharmaceutical market of the Russian Federation, including those with INN febuxostat. These drugs differ in excipients composition, in the dosage form (tablets and capsules) and production technology. The Dissolution Kinetics Test was chosen to assess the rate and extent of active ingredient release for drugs with INN febuxostat for different manufacturers as in vitro test dissolution allows to suggest the release from the dosage form in vivo. The rate and percent of active substance release are factors that have a direct impact on the bioavailability of drugs. Drug release was studied in a phosphate buffer solution pH 6.8, sampling was carried out at time points 0 min, 5 min, 10 min, 15 min, 20 min, 30 and 45 min. The analysis of the obtained solutions was carried out using the UV spectrophotometry method at a wavelength of 317 nm. The comparison of dissolution profiles was carried out in accordance with the requirements of Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 N 85 "On approval of the Rules for conducting bioequivalence studies of medicinal products within the framework of the Eurasian Economic Union". The purpose of the study. The purpose of this study was to compare the kinetics of the release of the active substance febuxostat from drugs registered in the territory of the Russian Federation in the form of tablets and capsules. Materials and methods. Drug release studies were performed using the Sotax dissolution tester AT Xtend, Switzerland. Each drug was analyzed in 12 repetitions in a pH 6.8 phosphate buffer dissolution medium, on a "Paddle apparatus", special sinkers were used for capsule dosage forms. The selected samples were analyzed on a Shimadzu UV 1800 UV spectrophotometer, Japan, at a wavelength of 317 nm. Results. Dissolution profile studies for three drugs with the active substance febuxostat were conducted in a phosphate buffer solution pH 6,8. For the studied drugs, the release of febuxostat was observed to be more than 85 % at 15 minutes. The release profiles can be recognized as equivalent without further mathematical processing. Conclusion. Based on the results of dissolution profile studies, no differences were found in dissolution profiles of febuxostat from drugs with different dosage forms (tablets and capsules).

Introduction. As part of a comparative assessment of drugs quality available on the Russian market a dissolution profile studies and uniformity of dosage units test was conducted for various manufacturers of "Captopril" drugs. Drug release studies in three dissolution media (0.1 M hydrochloric acid, acetate buffer pH 4.5, phosphate buffer pH 6.8) with sampling at 0, 5, 10, 15, 20, 30 min and analysis using UV/Vis spectrophotometer at 212 nm were conducted. Dissolution kinetics was compared based on calculation of the similarity factor f2 and the values of relative standard deviations. Uniformity of dosage units test of scored tablets were evaluated based on HPLC-UV analysis and AV factor calculation.Aim. The purpose of this study was a comparative evaluation of "Captopril" drugs from various manufacturers on the Russian market based on dissolution profile studies and uniformity of dosage units test of scored tablets in order to assess the quality of the tablets.Materials and methods. To prove the dissolution profile studies DT 827/1000 tester (ERWEKA GmbH, Germany) was applied. Each drug in three dissolution media in 12 replicates for each dissolution medium was analyzed. The selected samples were analyzed on a UV 1800 UV spectrophotometer (Shimadzu, Japan) at a of 212 nm. In uniformity of dosage units test of scored tablets each tablet was divided according to the applied mark. Sample preparation was carried out in accordance with a validated method and samples were analyzed by HPLC-UV using Agilent 1260 (Agilent Technologies, США).Results and discussion. Based on the results of dissolution profile studies and calculations of the similarity factors and values of the relative standard deviation it can be concluded that the dissolution kinetics for drug no. 4, drug no. 5, drug no. 6 are not equivalent in comparison with the reference drug. During the uniformity of dosage units test of scored tablets, no deviations were found in accordance with the requirements of the RF Pharmacopoeia OFS.1.4.2.0008.18 "Uniformity of dosing" and the EAEU Pharmacopoeia OFS.2.1.9.14 "Uniformity of Dosed Units".Conclusion. The conducted dissolution profile studies and uniformity of dosage for scored tablets of Captopril drugs show the example of possibility to identify potential problems with drugs quality presented on the Russian market and as a result improve and maintain quality assurance of drugs for the national healthcare system.