Analytical Method Development of Aspirin by Hydrotropic Solubilization Technique: QbD

Aspirin (acetylsalicylic acid) is a widely used drug with poor water solubility, which limits its analysis using conventional methods that rely on toxic organic solvents. This study aimed to develop a simple, accurate, and eco-friendly UV spectrophotometric method for estimating aspirin using hydrotropic solubilization with safe agents such as sodium benzoate and urea. Forced degradation studies were performed under thermal, pH, and concentration stress conditions to assess stability, and method optimization was carried out using a Quality by Design (QbD) approach with Box-Behnken design. The developed method demonstrated good linearity, precision, accuracy, and robustness, effectively monitoring aspirin stability while eliminating the need for harmful solvents. Hydrotropic solubilization combined with UV spectroscopy offers a cost-effective, environmentally friendly, and reliable approach for routine pharmaceutical analysis of poorly soluble drugs.