Abstract

A VALIDATED INHERENT STABILITY–INDICATING HPLC METHOD FOR ESTIMATION OF PALIPERIDONE IN THE BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

M. T. Harde*, S B. Wankhede and P D. Chaudhari

ABSTRACT

A rapid, accurate, linear, and sensitive RP-HPLC method has been developed and validated for estimation of Paliperidone in the bulk and Pharmaceutical Dosage Form. The chromatographic separation was performed on C18 Column (250 mm × 4.6 mm, 5 μm particle size) using a mobile phase Methanol: Phosphate buffer : Water (40: 35 : 25, v/v/v, pH 3.5) at flow rate of 1.0 ml/min and 25°C column temperature with the detection wavelength at 227 nm. The linearity study was performed in the concentration range of 5 to 25 μg/ml for Paliperidone with correlation coefficient was found to be 0.999. The percentage purity of Paliperidone was found in the range of 98-101%. The limit of detection was 0.34μg/ml and limit of quantification was 1.01 μg/ml. The Proposed method has been validated for which were within the acceptance limit according to ICH guidelines. The obtained results using RP-HPLC-DAD indicates the develop method is specific. Forced degradation conditions like hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress was successfully studied.

Keywords: Paliperidone; Validation; Force degradation studies.