A REVIEW ON THE PHARMACODYNAMICS, PHARMACOKINETICS, AND ANALYTICAL METHODS FOR ESTIMATION OF IGURATIMOD IN DOSAGE FORMS

Iguratimod is a novel synthetic disease-modifying anti-rheumatic drug (csDMARD) primarily utilized for the treatment of rheumatoid arthritis. Distinguished by its multiple mechanisms of action immunomodulatory, anti-inflammatory, and bone-protective Iguratimod suppresses the production of key inflammatory cytokines such as TNF-α, IL-1β, IL-6, IL-8, and IL-17, and inhibits nuclear factor kappa B (NF-κB) activation. Furthermore, it modulates B and T cell function, decreases immunoglobulin production by B cells, and prevents bone resorption by inhibiting osteoclast differentiation. Analytical methods for the quantification of Iguratimod include official pharmacopoeia assays (HPLC, dissolution) and a range of reported approaches such as UV spectrophotometry, RP-HPLC, HPTLC, and LC-MS/MS. These validated techniques ensure the safety, efficacy, and quality of Iguratimod formulations. This review provides an overview of the mechanisms, pharmacokinetics, pharmacodynamics, clinical utility, and available analytical methods for Iguratimod as an anti-rheumatoid agent, highlighting its promise for broadening treatment options and improving outcomes in rheumatoid arthritis management.