SYSTEMATIC REVIEW ON HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ANTI-LEPROTIC PHARMACEUTICALS - A PUBLICATION-READY REVIEW

Leprosy (Hansen’s disease) remains a public-health concern in several regions despite multidrug therapy (MDT) campaigns. Accurate, stability-indicating, and validated analytical methods are essential for quality control of anti-Leprotic pharmaceuticals (ALPs) in bulk, formulations and biological matrices, for stability studies, therapeutic drug monitoring (TDM) and pharmacokinetic investigations. High-Performance Liquid Chromatography (HPLC), including UHPLC and hyphenated variants (HPLC–MS/MS), is the most widely used technique for quantifying ALPs such as Dapsone, rifampicin, Clofazimine, Ofloxacin, minocycline and macrolides used in alternative regimens. This systematic review synthesizes method development strategies, chromatographic choices, sample preparation techniques, detector selection, forced-degradation approaches, validation practices (ICH Q2 (R1)), and modern trends (AQbD, green chromatography, UHPLC, miniaturization) as applied to anti-Leprotic drug analysis. We identify methodological gaps, common pitfalls, and propose best-practice recommendations for future method development and regulatory submission. The review follows a structured approach to searching, selecting, and summarizing primary analytical studies and method papers (see Methods).