Desenvolvimento e validação de método por CCDAE para análise de ticagrelor em comprimidos

Abstract

Ticagrelor is the first reversible inhibitor to P2Y12 receptor, approved for FDA for the prevention of thrombotic events such as stroke, heart attack in patients with ACS or myocardial infarction. The objective of this study was to develop and validate a method for the analysis of Ticagrelor in tablets using HPTLC and compare it to HPLC. For the development of the method, Thin Layer Chromatography (TLC) aluminium plates precoated with silica gel 60 F254 (20 x 20 cm) were used as stationary phase and mobile phase was composed of acetone : toluene (6 : 4 v / v). The analysis was performed at a wavelength of 255 nm and the Rf was approximately 0.47. The drug was exposed to oxidative degradation and photodegradation, where it was possible to observe peaks indicating the presence of degradation products. The method proved to be specific, linear, precise and robust. However, accuracy results were not satisfactory under the condition studied. There was a statistical significative difference in the comparison between HPTLC and HPLC methods, which may be related to the recovery, particle size of the stationary phases and mode of detection of each method.