STABILITY‑INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR DRUGS USED IN URINARY TRACT INFECTIONS: A COMPREHENSIVE REVIEW

Urinary tract infections (UTIs) are among the most prevalent bacterial infections worldwide and are treated with a wide range of antibacterial agents, including β‑lactams, Fluoroquinolones, Sulfonamides, Nitrofurans, Fosfomycin, and Aminoglycosides. Ensuring the quality, safety, and efficacy of these drugs requires robust analytical methods capable of accurately quantifying the active pharmaceutical ingredient (API) in the presence of degradation products and impurities. Stability‑indicating high‑performance liquid chromatography (HPLC) methods have therefore become indispensable tools in pharmaceutical analysis and regulatory compliance. This comprehensive review critically discusses the principles and practical aspects of stability‑indicating HPLC method development and validation for drugs used in UTIs. Detailed coverage is provided on drug classification, degradation behavior, chromatographic method development strategies, forced degradation studies, method validation parameters in accordance with ICH guidelines, and trends in the published literature. Current challenges and future perspectives, including the transition to UPLC and green analytical chemistry approaches, are also highlighted.