Analytical methods for the estimation of paliperidone

Abstract

Four simple, sensitive, rapid and accurate analytical methods have been developed for the estimation of paliperidone in bulk and pharmaceutical dosage forms. Paliperidone is an atypical antipsychotic. Methond I was a precise reverse phase HPLC involving an isocratic elution of Paliperidone in a column of Pkenomenex CIS, using a mobile phase composition of acetonitrile: Methanol: Potassium dihydrogen phosphate (45:30:25, v/v). The flow rate was 1.0 ml/min and the effluent was monitored at 275 nm and retention time was observed at 4.15 mm. Forced degradation studies were carried out in acid and basic medium, oxidative degradation in H2O2 and as well as uv photo stability studies. Methnd H & HI are visible spectrophotometnc methods based on the formation of red colored complex between Paliperidone and PDACA which showed linearity in the concentration range 20-120 |ig/ml and between Paliperidone and 4-Amino phenazone in red colored chromogen which obeyed Beer's law 30-150 |ig/ml at absorbance maxima of 460 nm and 532 nm respectively Method IV was a simple ultraviolet spectroscopic method was developed for the estimation of Paliperidone in 0.1N HC1 which obeyed Beer's law in the linearity range 5-25 |ig/ml at 275 nm. The proposed methods are optimized and validated as per the ICH guidelines. Recovery of paliperidone in the proposed methods was found to be in the range of 97.5-99.2 %. The proposed methods can be used for routine analysis for the estimation of paliperidone in formulations.