Abstract

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

Gali Haritha*, Shaik Naziya Fathima, Arunabha Mallik

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.

Keywords: Tuberculosis (TB), HPLC, Method Development, Validation, AQbD, Isoniazid, Rifampicin, Pyrazinamide, Ethambutol, Fluoroquinolones, Linezolid, Bedaquiline, Delamanid, and Pretomanid.