Analytical method validation for pharmaceutical equivalence study of hydroxychloroquine sulfate tablets

Hydroxychloroquine sulfate (HCQS) is an antimalarial agent, also used to treat rheumatoid arthritis (refractory acute or chronic) and lupus erythematosus (systemic or chronic discoid). It is available as a generic and similar drug in 400 mg tablets [2,3]. The current edition of the Brazilian Pharmacopoeia has no specific monograph for HCQS. Thus, it was intended to develop and validate the analytical method for quantification of the active pharmaceutical ingredient (API) as part of the pharmaceutical equivalence studies. The technique chosen was high performance liquid chromatography (HPLC). The validation of the method follows the requirements of Resolution RDC 166/2017 [1]. The developed method has demonstrated adequacy of the chromatographic system with favorable theoretical plate conditions, resolution, asymmetry and consistent retention time of the drug. The linear correlation in the working concentration ranges demonstrated applicability for the quantification of the active in 400mg dose HCQS medicines, besides good precision and recovery.