Development and Validation of Spectrophotometric Method for the Determination of Risperidone in pure and Pharmaceutical Formulation using MBTH reagent

A simple, sensitive, precise and accurate UV-Visible spectrophotometric method has been developed for the determination of Risperidone in bulk drug and pharmaceutical formulation (tablet). The method is based on the oxidative coupling reaction of the drug with 3-Methyl-2-Benzthiazolinone hydrochloride (MBTH) in the presence of Ferric chloride Fe (III) to form green coloured chromogen exhibiting λ max at 666nm. Beer's law was obeyed over the concentration range of 4–14μg/ml with a linear regression value 0.993.The method was validated in accordance with the current ICH guidelines. Interday and Intraday studies showed high degree of repeatability, recoveries obtained do not differ significantly from 100% showed accuracy and reliability of the method. The proposed method was applied successfully for the determination of Risperidone in pure bulk form and in tablets without interference from commonly encountered additives.