Search academic texts

Information × Registration Number 0222U005022, 0120U104201 , R & D reports Title Development of original combinations of antihypertensive agents, their analysis and standardization. popup.stage_title Head Logoyda Liliya S., Доктор фармацевтичних наук Registration Date 08-12-2022 Organization I. Horbachevsky Ternopil State Medical University popup.description2  Report on the GDR: 431 pages, 115 figures, 162 tables, 269 sources. ANTIHYPERTENSIVE DRUGS, PHARMACEUTICAL ANALYSIS, VALIDATION, BIOEQUIVALITY. The object of the study: methodological approaches to the development and validation of spectrophotometric and chromatographic methods for the determination of antihypertensive APIs in medical devices. Subject of study: API and tablets/capsules of valsartan, atenolol, lisinopril, metoprolol, atorvastatin and meldonium. Research methods: high-performance liquid chromatography with UV detection (HPLC/UV), high-performance liquid chromatography with double mass spectrometric detection (HPLC/MS/MS), thin-layer chromatography (TLC), absorption spectrophotometry in the ultraviolet (UV) and visible regions; methods of modeling analysis and visualization of multidimensional data - validation methods, regression and correlation analysis, determination of tablet dissolution profiles, as well as study of permeability through the intestinal membrane (Saso-2 test). Spectrophotometric methods for the determination of valsartan in substances and medicinal products by reaction with bromophenol blue (BPS) and methyl red (MCH) have been developed and validated. Valsartan forms ion-pair complexes selectively with dyes, as evidenced by the formation of a colored complex with BPS at pH 5.5 with ? max at 424 nm and MC at pH 4.3 with ? max at 494 nm. The formed ionic associates are poorly soluble in water, but in optimized experimental conditions they are soluble and do not require extraction with organic solvents, which is a significant advantage of the developed analytical methods. Optimization of spectrophotometric determination conditions is necessary for rapid and quantitative formation of colored complexes of ion associates with maximum stability and sensitivity. Maximum absorption was observed in methanol solution with BFS, while ethanol, propanol, chloroform, acetonitrile and ethyl acetate were unusable. Product Description popup.authors popup.nrat_date 2022-12-08 Close