Burmaka O. Development and validation of methods for quality control of the active pharmaceutical ingredient and finished dosage forms of enisamium iodide

In virtue of the analysis of available literature data regarding the quality control of the active pharmaceutical ingredient enisamium iodide and its finished pharmaceutical forms, it was concluded that the control methods are not sufficiently described. The method of quantitative determination of API by the HPLC was developed and validated. The developed method for control of the related substances in the API was used as a base for development of the Assay test of enisamium iodide in the API. The necessary corrections (to improve characteristics of the main peak) of analytical method were performed. The quality control methods of tablets and capsules such as «Assay», "Related substances" and «Dissolution profiles» were developed. The novelties of the proposed research work are as follows. The author for the first time developed and validated HPLC methods and methods of ultraviolet absorption spectrophotometry for quality control API and finished drug products of enisamium iodide. The developed methods of quality control are implemented at Farmak JSC. The validation results of analytical methods are used during preparing the registration materials intended for registration/renewal procedures in Ukraine and other countries of the world.