Chornyi I. Development of methods for quality control of medical preparations of benzydamine hydrochloride from the position of “green chemistry”

The dissertation covers the development and validation of analytical methods for quality control of oromucosal preparations with benzydamine hydrochloride according to the principles of "green chemistry". A "decision tree" for the selection of analytical methods based on their compliance with the principles of "green chemistry" has been developed, and the research methodology has been devised based on the results of its implementation. A method for determination of related substances in benzydamine hydrochloride spray and solution by HPLC has been developed. Forced degradation studies of the drug product have been conducted. Approaches to the identification of benzydamine and its metabolite in the presence of NSAIDs have been proposed. Methods for simultaneous determination of API (benzydamine hydrochloride) and preservative (methyl parahydroxybenzoate) by HPLC and GC methods have been developed. The optimal conditions of sample preparation and chromatography were determined, their validation was performed. A method for determination of residual amounts of API on the surface of the equipment by absorption spectrophotometry has been developed. A method for the simultaneous determination of benzydamine, menthol and methylparaben in the original combined dosage form by GC method has been developed. The developed methods correspond to the principles of "green chemistry" and are correct according to the results of validation studies.