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Article . 2026
License: CC BY
Data sources: Datacite
ZENODO
Article . 2026
License: CC BY
Data sources: Datacite
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STABILITY‑INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR DRUGS USED IN URINARY TRACT INFECTIONS: A COMPREHENSIVE REVIEW

Authors: G. Haritha1*, Arunabha Mallik2, Chavana Pranaswi1, Antarakshit Datta1, Cheguri Prasanna1, Gurrampally Apphia1;

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

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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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
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