LCMS Method Devlopment and Validation of Paliperidone in Formulation Dosage

A simple, precise and accurate RP-HPLC method was developed and validated for rapid assay of Paliperidone tablet dosage form. Isocratic elution at a flow rate of 1ml/min was employed on a symmetry Chromosil C18 (250x4.6mm, 5µm in particle size) at ambient temperature. The mobile phase consisted of Methanol: Acetonitril: Water 60: 10: 30 v/v, (PH 4.8). The UV detection wavelength was 237nm and 20µl sample was injected. The retention time for Paliperidone was 4.8min. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Paliperidone tablet dosage form and bulk drug.