Abstract
Author(s): MD. Shabana Sulthana, V. Anuradha and Mandava V Basaveswara Rao
A HPLC method for the estimation of direct acting and reversible P2Y12-ADP receptor blocker, Ticagrelor and its stability indicating study was developed and validated according to ICH guidelines. Stress testing was carried out under aqueous, acidic, alkaline, oxidative, photolytic and thermolytic conditions. The degradation was observed in alkaline and oxidative conditions and the drug remained stable in other applied conditions. Good elution pattern was achieved on X-Select CSH Phenyl-Hexyl column (150mm X 4.6mm i.d., 3.5μm particle size) using mobile phase comprising of 70% methanol in water. Reference compounds of these degradants were obtained using semi preparative HPLC purification. Degradants were characterized by Mass spectrometry and Nuclear magnetic resonance spectroscopy. The formed degradants are confirmed to be deEthylated and diasteriomeric N-oxide products of ticagrelor. The developed method was validated for linearity (10-60 μg/mL), precision (RSD ≤ 3.893%), accuracy (recovery 98 – 101%) and sensitivity (LOD 0.1μg/mL). This method is simple and convenient for the assay of ticagrelor in dosage form and its stability indicating study.