Table of Contents
Chromatography Research International
Volume 2011 (2011), Article ID 256812, 10 pages
http://dx.doi.org/10.4061/2011/256812
Research Article

Stress Degradation Behavior of Paliperidone, an Antipsychotic Drug, and Development of Suitable Stability-Indicating RP-LC Method

1Department of Research and Development, Megafine Pharma (P) Ltd., Nashik 422 202, India
2Department of Chemistry, Deogiri College, Aurangabad 431 004, India

Received 9 February 2011; Accepted 5 April 2011

Academic Editor: Wenkui Li

Copyright © 2011 Sanjay A. Jadhav et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A new, simple, rapid, and stability-indicating reversed phase liquid chromatographic (RP-LC) method for the determination of both assay and related substances in paliperidone has been developed and validated. During the forced degradation at hydrolysis, oxidative, photolytic, and thermal stressed conditions, the degradation was observed in the oxidative and acid stress conditions. Five process-related impurities (Imp-A to Imp-E) in test sample of paliperidone have been detected using newly developed RP-LC method. Among the five, Imp-C and Imp-D were found to be degrdants. Good resolution between the peaks corresponding to degradation and process-related impurities from the analyte was achieved on a Hypersil BDS C18 ( 2 5 0 × 4 . 6  mm, 5 μm) column. The stress samples were assayed against a qualified reference standard, and the mass balance was found to be close to 99.0%. The method was validated as per ICH guideline and was found to be robust. The proposed RP-LC method was successfully applied to the analysis of commercial formulation and was found to be specific and selective.