Development Of A Method For Identification And Validation Of A Drug Model Mixture Usingthin-Layer Chromatography

Abstract

The article presents studies on the development of a method for identifying ibuprofen, papaverine and dibazole in a model drug mixture using the TLC method. According to the results of chromatography "System", "Phase mobility" of the studied substances in individual solvents in different ratios, it was found that the system of chloroform – ethanol – ammonia conc. (1:1:0.5) is more suitable and provides optimal mobility. The polarity of the combined eluents was estimated by the value of the dielectric constant and the volume fraction of individual solvents included in the PF. It is shown that the developed end-to-end method for assessing the quality of the main active substances in the model medicinal mixture can be used in combined dosage forms.  Validation parameters such as the specificity and reproducibility of the developed TLC technique were also determined, studied on various chromatographic plates, and its reliability was evaluated based on the obtained Rf parameters. The results of validation of the TLC technique revealed its sensitivity, selectivity, and reproducibility, which will be very important (according to the requirements of the international harmonized standards for quality control ICH) for the analysis of the finished dosage form of antihypertensive action containing ibuprofen, papaverine, and dibazole.