Sensitive Method for the Quantitative Determination of Risperidone in Tablet Dosage Form by High-Performance Liquid Chromatography Using Chlordiazepoxide as Internal Standard

摘要

A selective, sensitive and simple reversed-phase HPLC method for the determination of risperidone in bulk powder and pharmaceutical formulations was developed and validated. Risperidone can be separated on a Supelcosil LC8 DB column (250 mm × 4.6 mm i.d., 5 μm particle size) at 40°C with a mobile phase of methanol and 0.1 M ammonium acetate pH 5.50 (60:40, v/v), pumped at flow rate 1.0 mL min^-1 and detected at 274 nm. Chlordiazepoxide hydrochloride was used as internal standard. The retention time of risperidone and chlordiazepoxide hydrochloride was found to be 5.89 and 7.65 min, respectively. The validation of the proposed method was carried out for specificity, linearity, accuracy, precision, limit of detection, limit of quantitation and robustness. The linear range was 4.0-275.0 µg mL^-1 (r²=0.9998) with limits of detection and quantification values of 0.48 and 1.59 μg mL^-1, respectively. The precision of the method was demonstrated using intra- and inter-day assay RSD values which were less than 3.27%, while the recovery was 99.00-101.12% (n=5). According to the validation results, the proposed method was found to be specific, accurate, precise and could be applied to the quantitative analysis of risperidone in raw material and tablets.