A Novel RP-HPLC-DAD Method Development for Anti-Malarial and COVID-19 Hydroxy Chloroquine Sulfate Tablets and Profiling of In-Vitro Dissolution in Multimedia.

Abstract

Abstract Hydroxychloroquine sulfate is one of a large series of 4-aminoquinolines with antimalarial activity. Moreover, it is used for the treatment of rheumatoid arthritis. Sometimes Hydroxychloroquine sulfate is very effective for the treatment of autoimmune diseases. Based on the recent clinical experiments it is exploiting for the treatment of COVID-19, corona virus across the globe. A Reverse phase RP-HPLC method have been developed and validated as per the current ICH guidelines for estimation of Hydroxychloroquine sulfate tablets. As part of method validation specificity, linearity, precision and recovery parameters were verified. The concentration and area relationships were linear (R2 > 0.999), over the concentration range of 25 to 300 µg mL-1 for HCQ. The relative standard deviations for precision and intermediate precision were less than 1.5%. The proposed RP-HPLC generic method was applied successfully for evaluation of invitro dissolution profile with different pH conditions like 0.1N HCl, pH 4.5 Acetate buffer and pH 6.8 Phosphate buffers of US marketed reference product.