title: Identification of impurities in artemisinin, their behavior in high performance liquid chromatography and implications for the quality of derived anti-malarial drugs.
abstract: Previous work [1] on the HPLC analysis of artemisinin tentatively identified the two impurities present above trace levels. This identification was based on LC-MS results and NMR of impurities isolated from artemisinin. In this work the impurities have been synthesized allowing verification of their identity by LC-MS. It is found that the previously suggested elution order is incorrect. A determination of relative response factors strongly impacts suggested limits on impurity levels and explains the erroneous peak assignment. The fates of the identified impurities are explored in the transformation of artemisinin to its derivative active pharmaceutical ingredients. A survey of a wide variety of artemisinin samples isolated from different geographical regions, different growing seasons, different plant backgrounds and using different extraction and purification approaches showed that artemisinin has sufficient purity for its intended use as a raw material for anti-malarial drug products.
authors.affiliation: Clinton Health Access Initiative, Boston, MA, USA. rstringham@clintonhealthaccess.org
authors.forename: Rodger W
authors.initials: RW
authors.lastname: Stringham
authors.forename: Michael
authors.initials: M
authors.lastname: Pennell
authors.forename: Walter
authors.initials: W
authors.lastname: Cabri
authors.forename: Giulio
authors.initials: G
authors.lastname: Carzana
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Giorgi
authors.forename: Silvana
authors.initials: S
authors.lastname: Lalli
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Marazzi
authors.forename: Marco
authors.initials: M
authors.lastname: Torri
mesh_terms: D000962:Antimalarials / Q000032:analysis* / Q000592:standards; D037621:Artemisinins / Q000032:analysis* / Q000592:standards; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004340:Drug Contamination; D011786:Quality Control
chemical_list: D000962:Antimalarials; D037621:Artemisinins; C031327:artemisinin