A Validated RP-HPLC Method for the Estimation of Paliperidone in Bulk and Tablet Dosage Form

A novel, precise and selective high performance liquid chromatographic method was developed for the estimation of paliperidone using paracetamol as the internal standard. Separation was achieved on a LiChrospher® RP-18 HPLC column (5 μ particle size and 25 cm × 4.6 mm internal diameter) using 10 mM ammonium acetate: methanol in the ratio of 10:90 (v/v) as the mobile phase, at flow rate of 0.7 ml/min and the eluate was monitored at 277 nm. The method was validated in compliance with ICH guidelines. The correlation coefficient of the calibration graph was 0.99946±0.00037 over the concentration range 1 to 5 µg mL-1. The limit of detection and limit of quantification were 0.569 µg mL-1 and 1 µg mL-1, respectively. Overall percentage recovery of paliperidone ranged between 98.92±0.595 to 100.30±0.693. Relative standard deviations for intra- and inter-day precision studies were