UHPLC Method Development of Validation for the Estimation of Ramipril and Metoprolol Succinate in Tablet Dosage Form

Abstract

This study aimed to develop and validate a novel Ultra-High-Performance Liquid Chromatography (UHPLC) method for the simultaneous quantification of Ramipril and Metoprolol Succinate in tablet formulations. The method, developed in compliance with International Council for Harmonization (ICH) guidelines, demonstrated high accuracy, repeatability, and low relative standard deviation (RSD) values of 0.49 for Ramipril and 0.59 for Metoprolol Succinate, confirming precision. An Agilent Technologies 1220 Infinity Series UHPLC system with a SUPELCO C18 column was used, with optimal mobile phase conditions and a flow rate of 0.7 mL/min. The method showed excellent resolution, symmetric peaks, and retention times of 0.677 minutes for Ramipril and 1.926 minutes for Metoprolol Succinate. Linearity was confirmed for concentrations ranging from 18.56 to 58.79 µg/mL for Ramipril and 25.10 to 75.15 µg/mL for Metoprolol Succinate. High recovery rates (98.95–100.19% for Ramipril and 100.05–100.18% for Metoprolol Succinate) confirmed accuracy, and the method's precision was validated by low %RSD values (0.84% for Ramipril and 0.23% for Metoprolol Succinate). This new UHPLC method is efficient, robust, and precise, offering valuable improvements for drug content assessment in pharmaceutical quality control.