A Validated Stability-indicating Hplc Method for Determination of Ticagrelor in Bulk and Its Formulation

A simple, rapid, accurate and precise stability-indicating HPLC method was developed and validated for the determination of Ticagrelor in bulk and its tablet dosage forms. Separation of the drug was achieved on Hypersil BDS C18 column (100 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of phosphate buffer pH 3.0 and acetonitrile in the ratio of 70: 30 V/V. The method showed a good linear response in the concentration range of 22.5-135 μg/mL with correlation coefficient of 0.999. The flow rate was maintained at 1.0 mL/min and effluents were monitored at 254 nm. The retention time was 3.215 min. The percentage assay of Ticagrelor was 99.9%. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and forced degradation studies. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of Ticagrelor in pharmaceutical dosage forms.