Determination of Risperidone and forced degradation behavior by HPLC in tablet dosage form

A simple, specific, sensitive, precise stability-indicating high-performance liquid chromatography method for determination of Risperidone in tablet dosage form was developed and validated. A Waters Xterra RP8 column (250*4.6 mm, 5 μ) in isocratic mode, with mobile phase consisting of a mixture of solution (10 mM potassium dihydrogen phosphate, pH 3.5 ± 0.05): acetonitrile: methanol (65:20:15) was used. The quantitation performed at flow rate of 1.0 mL/min at 276 nm and run time was 12 min. The analytical method was validated as per ICH guideline for linearity, accuracy, precision, specificity, limit of detection, limit of quantification, robustness and stability and method can be extended to the analysis of Risperidone in tablet formulations. the relative standard deviation values for precision was less than 2%, and % recovery was greater than 98% for risperidone. The drug undergoes oxidative degradation only.