Development, Optimization, and Validation of a Novel HPLC Method for Simultaneous Quantification of Artesunate and Amodiaquine in Tablet Formulations

Abstract

Artemisinin-based combination therapy (ACTs) has become the primary first-line treatment for mild falciparum malaria in the majority of African countries. A fixed-dose combination of amodiaquine and artesunate is commonly employed to enhance treatment compliance and achieve successful malaria outcomes. In this study, a specific, accurate, linear, precise, and repeatable method was optimized, verified, and applied for the simultaneous estimation of artesunate and amodiaquine HCl in a commercially available artesunate-amodiaquine tablet with a dosage of 100 mg/270 mg. The optimization process involved two steps. Firstly, the top three were carefully selected out of seven characteristics influencing the separation. These key elements required fine-tuning, namely the column type, ion pair, and the residual amount of acetonitrile (ACN) remaining after elution. In the second step, a Box-Behnken experimental design, coupled with Derrenguer's desirability approach, was utilized to identify the ideal target conditions. The optimized method demonstrated excellent specificity, accuracy, linearity, precision, and repeatability, allowing for the reliable simultaneous estimation of artesunate and amodiaquine HCl in the artesunate-amodiaquine tablet. This method offers a valuable tool for quality control and dosage determination in the pharmaceutical industry. By employing advanced experimental techniques and focusing on critical parameters, the study contributes to analytical methodologies in malaria treatment.