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Information × Registration Number 0221U102924, 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 11-02-2021 Organization I. Horbachevsky Ternopil State Medical University popup.description2  GDR report: 118 pages, 29 figures, 26 tables, 100 sources. ANTIHYPERTENSIVE MEDICINES, PHARMACEUTICAL ANALYSIS, BIOANALYTICAL METHODOLOGY, VALIDATION, BIOEQUIVALENCE. Object of research - Antihypertensive drugs (valsartan, atenolol, metoprolol, meldonium): substances and tablets of industrial and experimental production; blood plasma, monolayer of Saso-2 cells. The purpose of the study: development of analytical and bioanalytical methods for determining the original combinations of antihypertensive drugs and standardization of API in substances and drugs. Research methods: For the development of analytical and bioanalytical methods of analysis were used - UV spectrophotometry, HPLC / UV, HPLC / MS / MS, TLC; liquid-liquid extraction. The general methodology of development and validation of methods for identification and quantification of antihypertensive APIs in substances and drugs has been theoretically and experimentally substantiated, namely original methods for determination of valsartan and atenolol by HPLC and spectrophotometry in substances and tablets have been developed. The procedure of determination and criteria of acceptability of validation parameters of methods of quantitative determination of API from the ALS group for assessment of in vitro equivalence using chromatographic methods are experimentally substantiated. An original method for the quantitative determination of valsartan and atenolol for use in the dissolution kinetics test has been developed and validated. An original method has been developed and a list of validation parameters to be determined for methods for quantitative determination of analytes from the group of ALS in blood plasma has been selected. A unified procedure for validation of bioanalytical methods for the determination of metoprolol and meldonium for the study of pharmacokinetics is proposed. A bioanalytical method for determining valsartan to study intestinal membrane permeability (Saso-2 test) has been developed Product Description popup.authors popup.nrat_date 2021-02-11 Close