Objects – antihypertensive drugs (Amlodipine, Nifedipine, Verapamil, Captopril, Enalapril, Bisoprolol): substances and tablets of industrial and experimental production; blood plasma; Caco-2 cells monolayer; purpose – scientific and theoretical substantiation of analytical and bioanalytical researches of antihypertensive drugs (pharmacokinetics and equivalence, permeability through the intestinal membrane (Caco-2 test), dissolution kinetics) and standardization of active pharmaceutical ingredients in substances and drugs using chromatographic methods; methods – chromatographic methods of analysis (HPLC/UV, UHPLC/UV, HPLC/DAD, HPLC/MS/MS, TLC), liquid-liquid extraction, methods for modelling the analysis and visualization of multidimensional data (validation methods, regression and correlation analysis, determination of profiles dissolution of tablets, examination of permeability through the intestinal membrane (Caco-2 test)); novelty – theoretical and experimental basis of the general methodology of development and validation of methods of quantitative determination of analytes from a group of antihypertensive drugs in blood plasma, methods of identification and quantitative determination of antihypertensive active pharmaceutical ingredients in substances and drugs, developed and validated methods for the determination of antihypertensive active pharmaceutical ingredients for study the permeability through the intestinal membrane and for application in the test “dissolution kinetics”, validation of analytical and bioanalytical methods for the determination of antihypertensive active pharmaceutical ingredients, which allows to obtain comparative results from the substance of antihypertensive drugs (pharmacokinetics and equivalence, permeability through the intestinal membrane (Caco-2 test), dissolution kinetics) to standardization of antihypertensive active pharmaceutical ingredients in drugs using chromatographic methods; results – developed original chromatographic methods and unified procedures for validating the methods of identification and quantitative determination of antihypertensive active pharmaceutical ingredients in substances and drugs for the purpose of introducing in projects of monographs of SPhU for tablets of Amlodipine and Bisoprolol and for use in analytical laboratories, developed conditions for sample preparation of antihypertensive analysts for further bioanalytical researches, proposed and developed bioanalytical methods to determine the origin of analytes from the group of antihypertensive drugs in blood plasma for use in laboratories for the study of pharmacokinetics and bioequivalence of drugs for the use in vivo, proposed standard forms of validation protocols for quantitative bioanalytical determination methods for the study of pharmacokinetics and developed their electronic versions using the Microsoft Exсel software, which allows systematize the results of bioanalytical methodology, developed and validated methods of determination of antihypertensive active pharmaceutical ingredients for the study of permeability through the intestinal membrane (Caco-2 test), which can then be used by scientists to study the bioavailability and registration of drugs by the “biowaver” procedure, developed original methods of quantitative determination of active pharmaceutical ingredients from the group of antihypertensive drugs for the use in “dissolution kinetics” test in the study of bioequivalence of drug in vitro; implemented – in the scientific and pedagogical process of higher educational institutions, practice of pharmaceutical companies and the State Drugs and Medications Control Service in various regions of Ukraine; branch – pharmacy.
