ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RISPERIDONE AND BENZOIC ACID IN ORAL SOLUTION

Abstract

Using less toxic chemicals and time saving method for determination of the Risperidone (RIS) and Benzoic Acid (BA) was achieved with Waters XTerra (4.6 × 150mm, 5μm) stationary phase, using a UV detector at 275nm wavelength. The optimized mobile phase was consisted of potassium dihydrogen phosphate buffer (pH-3.00) and methanol (50:50 v/v). The retention times were 3.07 and 4.18 for RIS and BA respectively. Run time was 8 min, the flow rate was 0.8 ml/min and injection volume was 10 µl. The method was validated for specificity, linearity, solution stability, accuracy and precision. The method was specific, linear, accurate and precise. The method was linear within the range of 25% to 200% of the assay concentration (200 for RIS and 400 for BA). The method was accurate within the range of 50% to 200% of assay concentration. These methods can be used for qualitative and quantitative analysis of Risperidone and Benzoic Acid in a risperidone oral solution.