Stability-Indicating High Performance Liquid Chromatographic Method for Estimation of 9-Hydroxyrisperidone in Tablet Formulation

摘要

A stability-indicating high performance liquid chromatographic (HPLC) method for estimation of 9-hydroxyrisperidone (HRD) was developed and validated. HRD was separated and quantified on a Nucleosil C8 column (150 mm length, 4.6 mm id, 5 urn particle size) using a blend of methanol-ammonium acetate buffer pH 5.0 (95/05 v/v) as a mobile phase and at a flow rate of 1.3 mL/min. Quantification was achieved with a UV detector at 238 nm over a concentration range of 5-30 xg/mL. The applied HPLC method allowed separation and quantification of HRD with good linearity (r2 - 0.999) in the studied concentration range. The limit of detection and limit of quantification were found to be 1.04 and 3.16 |ig/mL, respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines. HRD stock solution was subjected to different stress conditions. The degraded product peaks were well resolved from the pure drug peak with significant differences in their retention time values. Stressed samples were assayed using the developed HPLC method. Statistical analysis of the data showed that the method is precise, accurate, reproducible, and selective for the analysis of HRD. The method was successfully applied for the estimation of HRD in tablet dosage form.