A Novel Validated RP-HPLC Method for the estimation of Ticagrelor in Bulk and Pharmaceutical Dosage Forms

Abstract

A reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of Ticagrelor in pharmaceutical dosage forms. The chromatographic separation of Ticagrelor was achieved on a Symmetry C18 column (250mm×4.6 mm, 5µm particle size), Agilent LC1220 HPLC system with UV detection (VWD detector) at 256nm. The optimized mobile phase was consisted of Methanol: Phosphate buffer (PH adjusted to 4 with orthophosphoric acid) (75:25 v/v). The flow rate was 1ml/min and effluents were monitored at 256nm. Chromatogram showed the main peak at a retention time of 2.750min. The method was validated for linearity, accuracy, precision, and limit of detection, limit of quantitation, robustness and ruggedness. The linearity was found in the concentration range of 5-50µg/ml. The Correlation coefficient was 0.999. The regression equation was found to be Y = 10290x+3252. The limit of detection and limit of quantitation for estimation of Ticagrelor was found to be 0.4 µg / ml and 1.28 µg / ml respectively. Recovery of Ticagrelor was found to be in the range of 99.57-99.97%. Proposed method was successfully applied for the quantitative determination of Ticagrelor in pharmaceutical dosage forms as per ICH guidelines.