A QbD-based method for the simultaneous determination of tadalafil, terazosin, and tamsulosin using organic-solvent free mixed-micellar HPLC: a sustainable green approach
Abstract
The recent updates to benign prostatic hyperplasia treatment from American (2023) and European (2024) guideline recommend the use of alpha-1 blockers in conjunction with phosphodiesterase-5 inhibitors. A new green mixed micellar liquid chromatographic method was established to concurrently analyze alpha-1 blockers, terazosin/tamsulosin, and tadalafil, a major phosphodiesterase-5 inhibitor. Quality by Design was integrated to enhance essential chromatographic variables and resulted in elevated desirability functions. A comprehensive design space was established, guaranteeing the method's reliability. The separation was carried out on a reversed-phase C18 column (150 × 4.6 mm, 5 µm) using organic-solvent-free mobile phase consisting of a mixture of Brij-35 (20 mM), sodium dodecyl sulfate (150 mM), and sodium dihydrogen phosphate buffer (10 mM) adjusted to pH 4.84 and flow rate of 1 mL/min. Ultraviolet detection was performed at 285 nm for tadalafil and 214 nm for terazosin and tamsulosin. The linearity range observed for all drugs under investigation was (5-100 µg/mL). The limits of detection were 0.27, 0.29, and 0.32 µg/mL, and the limits of quantification were 0.81, 0.88, and 0.97 µg/mL for terazosin, tadalafil, and tamsulosin, respectively. Validation in accordance with International Council for Harmonisation guidelines was successfully implemented. The approach was effectively utilized to identify analytes in the formulated tablets and pharmaceutical products. The…
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