STABILITY INDICATING HPTLC METHOD FOR THE ESTIMATION OF TICAGRELOR IN BULK AND IN PHARMACEUTICAL DOSAGE FORM

A simple, sensitive, and precise high-performance thin-layer chromatographic method has been developed for the estimation of Ticagrelor in pharmaceutical dosage form. The method employed Thin-layer chromatography (TLC) aluminum plates precoated with silica gel 60 F254 as the stationary phase, while the solvent system was found to be toluene: ethyl acetate: acetic acid (5:4:1V/V/V). The Rf value was observed to be 0.33± 0.008. The spot was densitometrically analyzed in absorbance mode at 305 nm. The method was linear in the range of 50-250 ng/ band for ticagrelor. The limit of detection for ticagrelor was found to be 0.826 ng/ band. The limit of quantification for ticagrelor was found to be 2.64 ng/band. Ticagrelor stock solution was subjected to acid and alkali hydrolysis, chemical oxidation, dry heat degradation and photo degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their Rf values. Stressed samples were assayed using developed HPTLC method. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of ticagrelor in its formulation.