Rosada M. Development and validation of quality control methods for riboxine in drug

Objects – riboksin in tablets and combined tablets with riboksin; aim – development and validation of methods of quality control of riboxin tablets, determination of residual amounts of riboxin on the surface of equipment in the production process and its combinations in dosage forms of industrial production in accordance with the requirements of SPhU; methods Physical and physical-chemical methods of analysis (absorption spectrophotometry in the UV and visible region, HPLC); novelty – the procedure of validation of the spectrophotometric method of the quantitative determination of riboxin in the finished medicinal product in the form of tablets was carried out, the spectrophotometric method of quantification of residual amounts of riboxin on the equipment at a concentration of 0.5 to 10.0 ppm (patent of Ukraine to utility model No. 114269) was developed and validated, the spectroscopy method for Riboxine quantitative determination after pharmaco-technological dissolution tests was developed and validated, the dissolution profiles of riboxin tablets have been investigated of various Ukrainian and foreign manufacturers, for the first time validation of the methods for determining the related impurities of hypoxanthine and guanosine in ribonine tablets by the HPLC method in accordance with the requirements of SPhU, An analytical procedure for the quantitative determination of L-arginine in the dosage form of Corargin, coated tablets, by high-performance liquid chromatography with UV-visible detection was developed and validated; results – the method of determination of residual amounts of riboxin on the surface of the equipment was developed and validated, the method of quantitative determination was adapted for the implementation of the "Dissolution" test of riboxin tablets. The dissolution profiles of riboksin tablets were investigated, the original method of determination of the related impurities (gipoxanthin, guanosine) in Rifoxin tablets was elaborated and validated. and the method of quantitative determination of riboksin and L-arginine in corrugin tablets was validated; introduced - into the manufacture, into the educational process of higher educational institutions; branch - pharmacy.