Chemometrically assisted optimization and validation of a new HPLC method for the determination of paliperidone in pharmaceuticals

Abstract

ABSTRACTPaliperidone is an antipsychotic drug, which is used for the acute and maintenance treatment of schizophrenia. In this study, a new method was developed for the determination of Paliperidone in its extended-release tablets. Face-centered central composite design was applied for optimization of the method. Factors were decided as acetonitrile content, pH of the mobile phase and buffer concentration through preliminary studies. Optimal flow rate (1 mL/min), column temperature (35°C) and internal standard (Bupropion) were also determined during preliminary studies. Retention factors and tailing factors of Paliperidone and Bupropion were selected as responses. Derringer’s desirability function was applied for simultaneously optimization of these four responses. Optimal conditions were predicted as phosphate buffer (pH:3, 23 mM): acetonitrile (76:24, v:v). Developed method was validated in terms of linearity, detection and quantification limits, accuracy, precision, specificity and robustness. Method was found linear in the concentration range of 0.125-100 µg/mL. Mean equation of the calibration curve was y = 0.0807 x - 0.0102 (R2 = 0.9999). Accuracy and precision of the method was evaluated with recovery values (98-102%) and relative standard deviation values (<2%), respectively. All other parameters were found acceptable. The method was successfully applied for the determination of Paliperidone in its extended-release tablets.