Chromatographic Simultaneous Estimation of Efonidipine Hydrochloride Ethanoate and Metoprolol Tartrate

Abstract

Background: Hypertension is a widely prevalent cardiovascular disorder associated with significant morbidity and mortality, and its effective management often necessitates combination drug therapy. Objectives: The present study was undertaken to develop and validate a Reversed-Phase High-Performance Liquid Chromatographic (RP-HPLC) method for the simultaneous estimation of Efonidipine hydrochloride ethanolate and Metoprolol tartrate in a fixed-dose combination using Simvastatin as an internal standard. Materials and Methods: Separation of the analytes was achieved on a C8 column using a mobile phase comprising (Acetonitrile: Methanol: Water) with the pH 3.0 using 1% orthophosphoric acid, in the proportion of 50:30:20 (v/v/v). The mobile phase was pumped at a constant flow rate of (1.0 mL/min), and detection was performed at 220 nm with a UV detector. Results: The retention times of Metoprolol, Efonidipine and Simvastatin were found to be 3.79 min, 5.74 min and 7.11 min, respectively. The method exhibited linearity over the concentration range of (10-320 µg/mL) for Efonidipine and (6.25-150 µg/mL) for Metoprolol, with correlation coefficients greater than 0.999. Conclusion: The developed method was validated in accordance with ICH guidelines for parameters such as accuracy, precision, sensitivity and robustness. The results demonstrated that the method is reliable and suitable for routine analysis of these drugs in pharmaceutical formulations.