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 (250×4.6 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.
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