Development and validation of stability indicating studies of paliperidone hydrochloride by RP-HPLC method

Abstract

A simple and sensitive stability indicating HPLC method is developed for the quantification of paliperidone in bulk and tablet dosage form. Chromatographic separation was achieved on a Supelco C8 (Hypersil, 250mm x 2.5mm i.d., 5 μm) column. The mobile phase consists of 10 mM ammonium formate buffer (pH 4.0): acetonitrile (73:27 v/v) and was delivered at a flow rate of 1 ml/min. The method was validated as per ICH guidelines. The linearity is obtained in the range of 1-15 μg/ml. The paliperidone was subjected to stress conditions for the assessment of the stabilityindicating nature of the method. Degradation products resulting from the stress studies have no interfere with the detection of paliperidone. The recovery of paliperidone in tablet dosage form was satisfactory. The developed method was proved adequate for quantitative determination of paliperidone in presence of its degradation products.

Key words: Analysis, HPLC, Paliperidone, Stability indicating, Tablets.