Abstract

Ticagrelor is an orally active, reversibly bind of the P2Y₁₂ receptor that can prevent ADP-mediated platelet activation and has a faster onset of action than clopidogrel. A stability-indicating HPLC method for the determination of ticagrelor in coated tablets was developed and validated. Chromatographic analysis was performed in a Shimadzu liquid chromatograph, equipped with Phemomenex^® C₁₈ column (250 x 4.6 mm, 5 μm), using a mobile phase composed of acetonitrile: water with 0.5% triethylamine (57:43 v/v) pH 7.0, at 0.7 ml/min flow rate and injection volume of 20 μl. Under the conditions established, the method demonstrated to be specific, without interference from formulation excipients, stability- indicating, linear (r = 0.9990) in the concentration range of 45.0 to 105.0 μg/ml, precise (RSD=0.71), accurate (99.61% of mean recovery) and robust. It can be successfully applied to ticagrelor tablets quality control, being adequate for routine analysis.

Keywords: Antiplatelet, HPLC, quality control, stability-indicating assay, tablets, ticagrelor.

Graphical Abstract