Method development and validation of ticagrelor in bulk and dosage form

Abstract

A simple, precise, rapid, specific and accurate reverse phase high performance liquid chromatography method was

developed for estimation of Ticagrelor in pharmaceutical dosage form. The method was developed in reverse phase

high Performance liquid chromatography using INERTSIL (Length 250mm x Dimension 4.6mm, Particle Size 5m)

column with mobile phase comprising of mixture of Methanol: Phosphate buffer (pH 2.5 adjusted with ortho

phosphoric acid) in ratio of 80:20 v/v, at flow rate of 1ml/min, with detection of 240 nm. The retention time of

Ticagrelor was found to be 4.8. Linearity of Ticagrelor was found in the range of 75-150 µg/mL with correlation

coefficient for Ticagrelor was 0.999. The LOD and LOQ values for Ticagrelor were 1.07 and 3.02 µg/mL

respectively. The method so developed was validated in compliance with the regulatory guidelines by using well

developed analytical method validation parameters like linearity, accuracy, precision, limit of detection and limit of

quantitation, robustness and ruggedness are in acceptable criteria.