An Improved Narrow-Bore LC Method for Quantification of Alfuzosin in Pharmaceutical Formulations

Abstract

A simple rapid and stability-indicating LC method using a narrow-bore column has been developed, fully validated, and applied to the quantification of alfuzosin in pharmaceutical formulations. Chromatography was achieved isocratically on a narrow-bore, 5-μm particle size, C₈ analytical column. The mobile phase was a 35:65 (v/v) 0.0125 m ammonium formate–acetonitrile at a flow rate of 0.35 mL min⁻¹. Detection was by UV absorption at 245 nm. Evaluation over the range 200–800 ng mL⁻¹ revealed linearity was good. Limits of detection and quantification for alfuzosin were 22.9 and 69.5 ng mL⁻¹, respectively. Intra-day and inter-day RSD were less than 6.4%, and the relative percentage error was less than −1.7% (n = 5). Accelerated degradation performed under different stress conditions including oxidation, hydrolysis, and heat, proved the selectivity of the procedure. The method was successfully used for quality-control and content-uniformity testing of commercial tablets.