A Novel RP-HPLC Method for the Development and Validation of Metoprolol Succinate in Bulk and Pharmaceutical Dosage Form

The objective of the present study was to develop and validate a simple, accurate, and robust reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the estimation of Metoprolol Succinate in bulk drug and marketed formulations. Chromatographic separation was achieved using a Phenomenex C18 column (250 mm × 4.6mm, 5µm) with an isocratic mobile phase consisting of Methanol and 0.1% Orthophosphoric Acid in Water (60:40 v/v) at a flow rate of 1.0mL/min. The detection was carried out at 222nm using a UV detector. The method demonstrated a good retention time with a total runtime of 6 minutes. The linearity of the method was observed in the concentration range of 5–15µg/mL with a correlation coefficient (R²) of 0.99994. The accuracy of the method was confirmed with a recovery of 99.40%, and precision results showed %RSD values well within the acceptable limit (<2.0%). The method also complied with ICH guidelines for parameters such as specificity, robustness, solution stability, and filter compatibility. The LOD and LOQ were calculated as 0.142µg/mL and 0.429µg/mL, respectively. Therefore, the developed RP-HPLC method is highly suitable for routine quality control analysis of Metoprolol Succinate in pharmaceutical formulations.