Application of Stability-indicating RP-HPLC Method for quantification of Ticagrelor In Oral dispersible tablet dosage form

Abstract

A simple, rapid, accurate and precise stability-indicating HPLC method was developed and validated for the determination of Ticagrelore in oral dispersable tablets. Separation of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. C18G column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of methanol and water in the ratio of 25: 75 v/v. The method showed a good linear response in the concentration range of 10-90 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 5.786 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and forced degradation studies. Stress conditions including acid, alkali hydrolysis, water stress, oxidation, photolysis, and heat were applied. The degradation products did not interfere with the detection of Ticagrelor, thus the method can be considered as a stability indicating method. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of Ticagrelore in oral dispersible tablets.