METHOD DEVELOPMENT AND VALIDATION OF TICAGRELOR AN ANTIPLATELET DRUG BY SPECTROPHOTOMETRY IN BULK DRUG AND PHARMACEUTICAL FORMULATION

In present work a simple, precise, accurate and cost effective extractive spectrophotometric method has been developed with Bromophenol Blue for determination of Ticagrelor in bulk and pharmaceutical formulations. It is based on the formation of an Ion Association complex between the drug and bromophenol blue in a buffer solution at pH 1.2 (0.1N HCl). The optimum conditions for the analysis of drug were established and lambda max was found to be 430nm. The developed method was validated as per guidelines of the International Conference on Harmonization (ICH)(1) including parameters like linearity, accuracy, and precision, limit of detection and limit of quantification. Linearity range was found to be 100-500 mu g/ml and the regression equation was Y=0.001963x-0.0463 with correlation coefficient of 0.999. From the results it was observed that good correlation exist between drug concentration and absorbance. The percentage recovery of Ticagrelor was found to be 100.3. The precision was evaluated and relative standard deviation (RSD) was less than 2%. The method was applied successfully to marketed formulation. The results suggest that this method can be employed for routine analysis of Ticagrelor in bulk and pharmaceutical formulations.