Analytical Method Development and Validation for Simultaneous Estimation of Nebivolol Hydrochloride and Amlodipine Besylate in Combined Pharmaceutical Dosage Form by Rp-Hplc

Abstract

Amlodipine Besylate and Nebivolol Hydrochloride, a fixed -combination drug is used to treat for hypertension and heart failure. These both (Amlodipine Besylate and Nebivolol Hydrochloride) drugs are soluble in ethanol, pH 1.2 and poorly soluble in water. Various parameters are collected including LOD, LOQ, Correlation, Coefficient and linearity, absorbance maxima, and retention time. A simple, rapid, and efficient Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Nebivolol and Amlodipine in combined pharmaceutical dosage forms. The chromatographic separation was achieved using an X-bridge C18 column (4.6 × 150 mm, 5 µm) at a column temperature of 35°C. The mobile phase consisted of Acetone and Methanol in a 65:35 (v/v) ratio, with a flow rate of 1 mL/min and detection at 220 nm. The method was validated for various parameters, including accuracy, precision, specificity, linearity, and robustness. The method demonstrated excellent resolution, sensitivity, and reproducibility, making it suitable for routine quality control analysis of Nebivolol and Amlodipine in combined dosage forms. The method is advantageous due to its simplicity, rapidity, and reliability, ensuring precise measurement of both drugs in pharmaceutical formulations.