World Journal of
Pharmaceutical and Life Sciences

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

G. Haritha*, Arunabha Mallik, Chavana Pranaswi, Antarakshit Datta, Cheguri Prasanna, Gurrampally Apphia

ABSTRACT

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.

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