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

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.

Authors

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2026-02-01
DOI
https://doi.org/10.5281/zenodo.18426964
Primary Topic
Tuberculosis Research and Epidemiology
Type
article
Field-Weighted Citation Impact
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article

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

Gali Haritha1*, Shaik Naziya Fathima2, Arunabha Mallik3
Zenodo (CERN European Organization for Nuclear Research)
Tuberculosis Research and Epidemiology
article

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

Gali Haritha1*, Shaik Naziya Fathima2, Arunabha Mallik3
article en

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.

Zenodo (CERN European Organization for Nuclear Research)
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Tuberculosis Research and Epidemiology
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