Development and validation of a generic method for determination of antimalarial drugs using high-performance thin-layer chromatography (HPTLC)

Abstract A HPLTC method as a generic, semi-quantitative for simultaneous analysis of six known antimalarial drugs was developed, validated and successfully applied to the marketed brands in the Democratic republic of Congo. The method characterized by its simplicity, rapidity, use in all quality control laboratories with simple equipment consisting of a spotter and UV-254 nm silica gel plates, and proved to be less expensive than HPLC. The method was validated over the entire assay range (500µg/ml to 1500 µg/ml) using the total error strategy. It showed a good specificity, resulting from the lack of interference with the matrices used at the fixed wavelength (254 nm). The method demonstrated to be faithful, fair and accurate. The method exhibited a good linearity in this assay range, with the determination coefficient close to the unity (R2= 0.9816). The limits of quantification (upper and lower) also were assessed and corresponded to the used assay range.