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A Validated Spectrophotometric Method for Determination of Paliperidone Palmitate in Bulk Drug and its Pharmaceutical Dosage Form

Rakshit Kanubhai Trivedi, Ravikumar Jupudi, Mukesh C Patel, Dipika R Trivedi, and Hitesh A Jogia

The present research describes simple, sensitive, rapid, accurate, precise and economical spectrophotometric method for determination of paliperidone palmitate in bulk and extended release injectable suspension formulation. The Paliperidone palmitate obtained spectrum was determined at 278 nm. The linearity was obtained in the concentration range of 15.6-50 μg/ml for Paliperidone palmitate. Interference due to placebo was not observed at 278 nm. The recovery and precision was well within the ICH (International conference on Harmonization) define criteria. The method was found to be simple and sensitive for the Paliperidone palmitate determination in injectable suspension dosage form. The results of analysis have been validated statistically and by recovery studies.