Abstract

FIRST ORDER DERIVATIVE UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TICAGRELOR IN PHARMACEUTICAL DOSAGE FORM

Manisha C. Chavan*, Pallavi Nayabrao Jumbad and Ujjwala Y. Kandekar

ABSTRACT

This study was aimed at development and validation of straightforward, accurate, precise, reproducible, and economical First order derivative UV-Visible Spectrophotometric method for estimating Ticagrelor in its solid dosage form. Methanol and Acetonitrile combination was used as the solvent throughout the experiment. Absorption maxima (λmax) of Ticagrelor was found 255 nm. The method obeyed Beer’s law and was liniar across the concentration 5-25 μg/ml with a correlation coefficient (R²) of 0.9995 and a regression equation of y=0.0362x-0.0117. Recovery of Ticagrelor was found between 100.27% and 101%. The relative standard deviation (% RSD) was found to be 0.209% for intra-day and 0.362% for inter-dayprecision. The detection limit and quantification limit were observed at 1.096 μg/ml and 2.0846 μg/ml, respectively. The method was validated statistically for parameters such as accuracy, precision, linearity, and solution stability, making it suitable for estimation of Ticagrelor in dosage form for routine laboratory analysis.

Keywords: Ticagrlor, validation, Ultraviolet-spectroscopy, Method development, linearity, solution stability.