High performance liquid chromatographic evaluation of artemisinin, raw material in the synthesis of artesunate and artemether

A barrier to the development of artemisinin derivative based combination treatment of malaria is the lack of defined specifications and purity test methods for the raw material artemisinin. An HPLC method previously published in the International Pharmacopoeia to evaluate purity of artemisinin as an active pharmaceutical ingredient is adapted for use. Excellent method precision and linearity are demonstrated along with observations of robustness. In support of the development of specifications major impurities are identified using high resolution HPLC–MS, isolation via preparative HPLC followed by NMR. The identified impurities differ from those previously claimed.