Abstract

DEVELOPMENT AND VALIDATION OF NEW SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF TICAGRELOR IN BULK AND PHARMACEUTICAL FORMULATION

*Dr. Gampa Tulja Rani and Devi Thamizhanban

ABSTRACT

In this study a sensitive, simple and accurate spectrophotometric method is suggested for the determination of Ticagrelor in bulk and pharmaceutical dosage form based on the formation of an ion-pair complex between the drug and bromothymol blue in a buffer solution at pH 1.2 (0.1N HCl). The optimum conditions for the analysis of drug is established and Ticagrelor was found to exhibit maximum absorbance at 414nm with chloroform as solvent. The present method is validated as per guidelines of the International Conference on Harmonization (ICH) including parameters like linearity, accuracy, and precision, limit of detection and limit of quantification. The Beer’s law is found to be in concentration range of 50-400μg/ml and the regression line equation is Y= 0.0032x - 0.0012 with correlation coefficient of 0.999. The percentage recovery is found to be 100.1-100.8%. The precision is evaluated and relative standard deviation (RSD) is found to be less than 2%. The values of LOD & LOQ are 0.32 & 1.09 respectively. The results suggest that this method can be employed for routine analysis of Ticagrelor in bulk and pharmaceutical formulations.

Keywords: Ticagrelor, Visible spectrophotometry, Bromothymol blue (BTB), Validation.