Integrated RP-HPLC approach for concurrent assay and dissolution analysis of artemether and lumefantrine: Leveraging MoGSA and RAPI

Abstract Artemether (ART) and lumefantrine (LUM), two key components in antimalarial combination therapy, were assayed simultaneously and tested for dissolution using RP-HPLC. The purpose of this study is to present an eco-friendly RP-HPLC method that is combined with RAPI and MoGSA tools in order to assure an environmentally friendly analysis of both artemether and lumefantrine. In this method, acetonitrile, water, n-propanol, and trifluoroacetic acid were combined in a 50:40:10:1 ratio (v/v), at a flow rate of 1.3 mL min −1 , to achieve chromatographic separation. The ART and LUM detections were performed using UV detectors set at 210 and 236 nm, respectively, for the first 6.6 and 21.1 min, respectively. Both analytes were linearly detected over the concentration range of 3–60 μg mL −1 , with high recovery rates confirming their accuracy. ICH guidelines were followed to verify method reliability and reproducibility. Under specified dissolution conditions, at least 80% of the active substance of conventional immediate-release tablets was released within 45 min. Over a period of six months, accelerated stability tests confirmed the formulation's stability under stress conditions. Furthermore, MoGSA and RAPI scores classified the method as green and white respectively. In view of its robustness and durability, the method is suitable for routine quality control of ART and LUM in pharmaceutical formulations.