Analytical Method Development and Validation of Prucalopride Succinate in Bulk and Formulation by UV-Visible Spectrophotometry

Abstract

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.

Integrated resonance Rayleigh scattering approach utilizing Box–Behnken experimental design for the facile quantification of prucalopride in pharmaceutical tablets and human urine with sustainability assessment

“…The reported chromatographic and electrochemical methods required tedious sample pretreatment steps, less green and expensive solvents and sophisticated instruments. On the other hand, few spectroscopic techniques were reported, including UV spectrophotometry [9][10][11][12][13] and luminescence-based reaction. [14][15][16] The spectrophotometric methods suffered from limited sensitivity.…”

An ingenious technique based on the usage of fluorone‐based dye; pyrosin B in prucalopride assay in different matrices through an “on–off” dye native fluorescence probe

“…Some techniques for examining PCD in both simple and complex combinations have been extensively debated in scientific literature. The studies that were conducted examined how to measure PCD through a variety of analytical methods, such as chromatography [4][5][6][7], electrochemical strategies [8,9] and spectrophotometry [10,11]. A procedure that uses a luminescent reaction [12] and spectrofluorometry [13,14] was also mentioned but there is no way to measure PCD in plasma samples or check PCD content uniformity in tablets.…”

Sensitive spectrofluorimetric determination of the prokinetic drug prucalopride succinate based on supramolecular aggregation approach with evaluation of method greenness: application to content uniformity test

“…For PCP analysis, literature reports document few spectrophotometric methods [3][4][5][6][7], spectrofluorimetric methods [8][9][10][11], chromatographic methods [12][13][14][15], and electrochemical methods [16,17]. The reported spectrophotometric methods had limited sensitivity.…”