HPLC ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ANTI-TUBERCULAR DRUGS: A COMPREHENSIVE REVIEW

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Authors: Gali Haritha1*, Shaik Naziya Fathima2, Arunabha Mallik3
Cited by: 0

Abstract

Tuberculosis (TB) remains a major global health challenge, necessitating highly reliable analytical methods for the quantification of first-line and second-line anti-tubercular drugs (ATDs) in pharmaceuticals and biological matrices. High-Performance Liquid Chromatography (HPLC) continues to be the most widely applied technique for routine analysis due to its selectivity, sensitivity, and robustness. This review provides an extensive discussion on chromatographic principles, method development strategies, validation parameters, and analytical challenges associated with ATDs such as isoniazid, rifampicin, pyrazinamide, ethambutol, fluoroquinolones, linezolid, Bedaquiline, Delamanid, and Pretomanid. Detailed literature summaries, forced degradation considerations, and future prospects of green chromatography, AQbD, and hyphenated techniques are highlighted.

Fields of Study & Subjects

Analytical Methods in Pharmaceuticals Analytical Chemistry and Chromatography Biosimilars and Bioanalytical Methods

Publication details

Journal / source
Zenodo (CERN European Organization for Nuclear Research)
Publication date
1 February 2026
Language
EN