Analytical method development and validation of prucalopride succinate in bulk and formulation by UV-Visible spectrophotometry

Purpose: Analytical method development and validation for the quantitative determination of Prucalopride succinate in bulk and tablet formulation which plays major role in the development and manufacture of pharmaceuticals. Methods: In the present work a simple, rapid and reproducible UV-Visible Spectrophotometric method was developed and validated according to ICH guidelines. Results and Conclusions: The parameters linearity, specificity, precision, accuracy, and robustness were studied. The wavelength 243nm was selected for the estimation of drug using methanol as a solvent. The drug obeys Beer-lambert's law over the concentration range 2–10μg/ml. The accuracy of the method was assessed by recovery studies and was found between 97.2–98.3%. The method was successfully applied for routine analysis of Prucalopride succinate in bulk and formulation.