title: High performance liquid chromatographic evaluation of artemisinin, raw material in the synthesis of artesunate and artemether.
abstract: 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.
authors.affiliation: Clinton Foundation, 383 Dorchester Ave., Suite 400, Boston, MA 02127, USA. rstringham@clintonfoundation.org
authors.forename: Rodger W
authors.initials: RW
authors.lastname: Stringham
authors.forename: Kenneth G
authors.initials: KG
authors.lastname: Lynam
authors.forename: Peter
authors.initials: P
authors.lastname: Mrozinski
authors.forename: Greg
authors.initials: G
authors.lastname: Kilby
authors.forename: István
authors.initials: I
authors.lastname: Pelczer
authors.forename: Christina
authors.initials: C
authors.lastname: Kraml
mesh_terms: D000077549:Artemether; D037621:Artemisinins / Q000032:analysis* / Q000138:chemical synthesis / Q000737:chemistry; D000077332:Artesunate; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D014466:Ultraviolet Rays
chemical_list: D037621:Artemisinins; D000077332:Artesunate; D000077549:Artemether