Comprehensive review on Alfuzosin quantification: Analytical techniques and the evolution of AQbD in method development

Alfuzosin is an alpha-adrenergic antagonist that is used in the treatment of benign prostatic hyperplasia. With a focus on spectroscopic and chromatographic techniques, this review critically examines the many analytical procedures developed for alfuzosin evaluation. The ease of use and minimal resource requirements of UV spectroscopic techniques have made them indispensable tools for routine quality control and early evaluations.In parallel, chromatographic methods particularly High-Performance Liquid Chromatography (HPLC) and the recently developed Ultra-Performance Liquid Chromatography (UPLC) systems have become the mainstay for quantifying alfuzosin in complex matrices due to their exceptional resolution, sensitivity, and specificity. Furthermore, the breadth of pharmacokinetic and bioequivalence investigations has expanded thanks to sophisticated hyphenated techniques like LC-MS/MS. Analytical Quality by Design (AQbD) concepts, which emphasize method robustness, lifecycle management, and systematic risk management, have brought about a paradigm change that is further explored in this paper. AQbD makes it easier to create techniques that are both optimal and comply with regulations by integrating tools such as multivariate analysis and Design of Experiments (DoE). This paper provides a thorough viewpoint for future technique development and validation for alfuzosin, highlighting the shift from conventional to contemporary, risk-based analytical strategies.