DEVELOPMENT AND VALIDATION OF PALIPERIDONE IN BULK AND PHARMACEUTICAL FORMULATION BY RP-HPLC
A simple, specific, accurate, and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of Paliperidone in pharmaceutical dosage form. The chromatographic separation of Paliperidone was achieved on a Verian C-18 column with 250 x 4.6 mm i.d. and 5 μm particle size, using UV detection at 238nm. The optimized mobile phase was consisted of Acetonitrile: Methanol: KH2PO4 buffer pH 2.5 (30: 30 : 40 v/v). The flow rate was 1ml / min and effluents were monitored at 238 nm. Chromatogram showed the main peak at a retention time of 2.586 ± 0.02 min. The linearity was found in the concentration range of 10-60 (μg/ml). The Correlation coefficient was 0.9998. The limit of detection and limit of quantitation for estimation of Paliperidone was found to be 0.038 (μg/ml) and 0.116 (μg/ml) respectively. Recovery of Paliperidone was found to be in the range of 99.97-100.03 %. Proposed method was successfully applied for the quantitative determination of Paliperidone in pharmaceutical dosage form.