Georgiyevs'kyj G. Analytical software for the synthesis, standardization and organization of manufacturing of derivatives of 1,2,4-triazole and their drug dosage forms

At the example of 1,2,4-triazole derivatives, for the first time, it was justified the development of a new scientific direction - analytical assurance for the development and quality control of drugs by the methodology of evidence-based algorithm. Prognosis and confirmation of pharmacological activity for 1,2,4-triazole derivatives which are products of chemical modification of Tiotriazoline and Kardiotril, were carried out; their structure and purity was proved, physicao-chemical and chromatographic characteristics studied were used for the development of a complex methods of the analysis; critical quality attributes and stability were studied and established, correctness of choice for the dosage forms was justified by pharmacokinetic studies. Results obtained were implemented into technical and analytical documentation for manufactures and the State Pharmacopoeia of Ukraine; specifications for APIs samples as MT and Lysiniy and technological impurities were developed for certification of reference samples for quality control. Documentation for registration was prepared. Performed by us scientific studies using our algorithm allowed us to create APIs: Lysiniy and MT and they dosage forms for injections, pharmacological effects of these APIs were higher than effects of structural analogues (tiotriazolin and cardiotril).