A simple reverse phase HPLC method was developed and validated for the assay of paliperidone in pure and tablets. The analysis was carried out on Shimadzu HPLC model equipped with inertsil ODS C-18 column, LC-10AT pump, variable wavelength programmable UV-Detector SPD-10AVP and rheodyne injector with 20 µL fixed loop. Acetonitrile and methanol in the ratio 10:90 v/v at a flow rate of 1.0 mL/min was employed for elution and the components were detected at 235 nm at ambient temperature. The method was validated as per the ICH guidelines. The retention time for paliperidone was found to be 5.67 min. Linearity was observed in the concentration range of 20-120 ppm with correlation coefficient 0.9990. The percent of relative standard deviation of six replicate measurements was found to be 1.25 indicate that the proposed method was precise. Recovery studies were conducted at three different concentration levels within the linearity limits and the average percent of recovery was 99.56. The amount of paliperidone drug content present in tablet dosage form was determined and found to be 99.80%. Therefore, the developed method was simple, precise and accurate and can be successfully applied for the estimation of paliperidone in pharmaceutical dosage forms.
Paliperidone, UV detection, Method Validation, Linearity and Assay