An Ecofriendly Novel Spectrophotometric Estimation and Validation of Paliperidone in Bulk Drug and their Dosage Forms by Mixed Hydrotropic Solubilisation Method

A novel, simple, safe, accurate and reproducible UV spectrophotometric method was developed using a hydrotropic blend of 20% sodium benzoate and 20% Niacinamide for the estimation of poorly water soluble drug Paliperidone in bulk and pharmaceutical dosage form. There were more than 87 fold solubility enhanced in hydrotropic blend as compared with distilled water. The Paliperidone shows the maximum absorbance at 286nm. At this wavelength hydrotropic agents and other tablet excipients do not shows any significant interference in the spectrophotometric assay. The developed method was found to be linear in the range of 10-50 µg/ml with correlation coefficient (r²) of 0.9990. The mean percent label claims of tablets of Paliperidone in two marketed formulation I and formulation II estimated by the proposed method was found to be 99.48 + 0.292 and 98.01 + 0.326 respectively. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values.