Development and Validation of a Rapid RP-HPLC Method for Assay and Dissolution analysis of Aripiprazole Tablets

Resumen

A rapid, accurate, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative estimation of aripiprazole in bulk drug and tablet dosage forms, including dissolution studies. Chromatographic separation was achieved using an Inertsil PH-3 phenyl column (100 mm × 4.6 mm, 5 μm) with a mobile phase consisting of buffer (pH 3.5) and acetonitrile in the ratio of 65:35 (v/v) for assay and 70:30 (v/v) for dissolution analysis. The flow rate was maintained at 2.0 mL/min, and detection was carried out at 217 nm. The developed method produced sharp and symmetrical peaks with retention times of 2.45 min for assay and 4.58 min for dissolution analysis. Validation was performed according to ICH Q2(R1) guidelines. The method exhibited excellent linearity over the concentration range of 24.24–72.73 μg/mL for assay with a correlation coefficient (R²) of 0.9998. Accuracy studies showed recoveries within 98–102%, while precision studies demonstrated %RSD values below 2%. Specificity studies confirmed the absence of interference from excipients and impurities. The method also proved robust against small deliberate variations in chromatographic conditions. The validated method was successfully applied for routine assay and dissolution testing of aripiprazole tablets. The developed RP-HPLC method is simple, rapid, economical, precise, and suitable for routine quality control analysis in pharmaceutical industries.