An eco-friendly HPLC method for the sustainable analysis of the newly approved combinations of Alfuzosin and Tamsulosin, with Tadalafil in organic-solvent-free mixed-micellar systems
Abstract
In 2019, 94.00 million prevalent cases of benign prostatic hyperplasia (BPH) were reported, accounting for 2.48% of the global population. BPH is a significant urological health concern worldwide, leading to considerable economic burdens. The European and American guidelines for lower urinary tract symptoms were recently updated in 2023/2024, supporting a combination therapy of alpha-1 blockers with phosphodiesterase-5 inhibitors. Moreover, patents describing this combination have been previously reported. In this work, a novel, totally green organic-solvent-free mixed-micellar liquid chromatography method was developed to simultaneously analyze alpha-1 blockers alfuzosin (ALF) and tamsulosin (TMS) and phosphodiesterase-5 inhibitor tadalafil (TAD). Response surface methodology was employed to optimize the critical chromatographic variables, and a design space representing the robustness zone was identified. Separation was achieved on an RP-C18 column (150 × 4.6 mm2, 5 μm) using a green mixture of Brij-35 (19.91 mM), SDS (130.00 mM), and sodium dihydrogen phosphate buffer (10.00 mM) at pH 4.65. The flow rate was set at 1.5 mL min-1, and UV detection was observed at 250, 285 and 214 nm for ALF, TAD and TMS, respectively. The method was validated over a concentration range of 5-100 μg mL-1 for all drugs with detection limits of 0.77, 1.23 and 1.59 μg mL-1 and quantification limits of 2.35, 3.73 and 4.82 μg mL-1 for ALF, TAD and TMS, respectively. The method was applied to…
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