title: Quality and stability of artemether-lumefantrine stored under ambient conditions in rural Mali.
abstract: BACKGROUND
  The quality and stability of anti-malarial drugs in the Global South has long been of significant concern. Drug quality can be affected by poor or fraudulent manufacturing processes, while drug stability is affected by temperature and humidity. Knowledge of drug quality and stability is often the unique contribution of pharmacists volunteering on short-term medical mission trips.
  
  
  OBJECTIVE
  To determine the quality and stability of artemether-lumefantrine 20/120 mg under ambient storage conditions in rural Mali.
  
  
  METHODS
  One unopened blister pack of artemether-lumefantrine 20/120 mg (IPCA Laboratories, Mumbai) was stored under ambient conditions in a warehouse in a Malian village for one year. A second pack from the same lot number was stored under temperature and humidity controlled conditions in a university laboratory. The active ingredients of tablets from both packages were analysed using thin layer chromatography, nuclear magnetic resonance and infrared spectroscopy. The IPCA samples were referenced for drug identity and content to an identical American made product (Coartem(®), Novartis Pharmaceuticals).
  
  
  RESULTS
  Thin layer chromatographs, nuclear magnetic resonance and infrared spectroscopy results were identical for both IPCA samples and the reference product.
  
  
  CONCLUSIONS
  The IPCA products contained the same drugs in the same amount as on their package label and were identical to the reference product. It is concluded that they were of good quality. Spectroscopy results demonstrate the sample stored in Mali was stable for one year. Pharmacists volunteering on medical mission trips may dispense this product with confidence. At the end of a mission trip, pharmacists may store left over artemether-lumefantrine under ambient conditions for up to one year without concern for significant degradation of the active ingredients.
authors.forename: John
authors.initials: J
authors.lastname: Gitua
authors.forename: Aaron
authors.initials: A
authors.lastname: Beck
authors.affiliation: College of Pharmacy and Health Sciences, Drake University, 2507 University Avenue, Des Moines, IA 50311, USA. John.Rovers@drake.edu.
authors.forename: John
authors.initials: J
authors.lastname: Rovers
mesh_terms: D000962:Antimalarials / Q000737:chemistry*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000737:chemistry*; D002855:Chromatography, Thin Layer; D004338:Drug Combinations; D004355:Drug Stability; D004356:Drug Storage; D004983:Ethanolamines / Q000737:chemistry*; D005449:Fluorenes / Q000737:chemistry*; D006801:Humans; D009682:Magnetic Resonance Spectroscopy; D008302:Mali; D012424:Rural Population; D013055:Spectrophotometry, Infrared; D013696:Temperature
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes