A Validated Rapid Reversed-Phase High Performance Liquid Chromatographic Method for Determination of Risperidone and Benzoic Acid

Abstract

A simple, sensitive and rapid reversed-phase high performance liquid chromatographic (RP-HPLC) method was developed for determination of risperidone (RSP) and benzoic acid (BZA) preservative. Analysis was achieved on an Equisil® BDS C18 column (250 x 4.6 mm, 5 μm) with an isocratic binary mobile phase composed of 0.05 M potassium dihydrogen phosphate (pH 2.5) and acetonitrile (65:35; v/v). The flow rate was 1.0 mL/ min and detection was carried out at 260 nm. Linear regression study revealed a good linear relationship over a range of 50–150 μg/mL for RSP and BZA, with a correlation coefficient (R2) of more than 0.999. Limit of detection (LOD) and limit of quantitation (LOQ) were 4.69 and 14.20 μg/mL, and 2.72 and 8.24 μg/mL for RSP and BZA, respectively. Intra- and inter-day precisions, calculated as percentage relative standard deviation (% RSD), were lower than 2.0 %. The proposed method was applied for the quantitation of RSP and BZA in pure form and in RSP pharmaceutical dosage form