Development and validation of RP- HPLC method for determination of ticagrelor in pharmaceutical dosage formulation

The quantitative determination of Ticagrelor in pharmaceutical dosage forms was developed by using a simple accurate precise and cost effective method. The separation was achieved by isocratic method using phenomenex C18 column on a Shimadzu binary gradient liquid chromatographic system equipped with LC-20AD solvent delivery system, SPD-20A photo diode array detector and rheodyne injector with 20 μl loop volume. The mobile phase developed for the estimation of the drug in dosage form and in human plasma contains a mixture of acetonitrile and methanol in the ratio of 70:30% v/v at a flow rate of 1 ml/min at a detection wavelength 254 nm. Retention time of Ticagrelor in pharmaceutical formulation was found to be 3.793 min with a run time of 7 min. The drug showed linearity in the range of 10-100 μg/ml with a correlation coefficient (r2) 0.9967.The results were found to be within the acceptance of ICH, USP guidelines. The described method was validated with respect to the system suitability parameters, linearity, precision and accuracy. Each solution was injected in triplicate, and %RSD was measured. The validation results obtained in the study shows that the proposed method can be easily and conveniently adopted for routine analysis of ticagrelor in pharmaceutical formulation.