title: Artemether-Lumefantrine Concentrations in Tablets and Powders from Ghana Measured by a New High-Performance Liquid Chromatography Method.
abstract: We developed and validated a new analytical method for the simultaneous quantification of artemether and lumefantrine in fixed-dose tablets and powders for reconstitution into pediatric suspensions (PSs). The method showed linearity (r(2) > 0.9947), precision (coefficient of variation < 2%), accuracy (deviation of mean from actual concentrations < 4%), and specificity (peak purities > 99%). The validated method was used to analyze 24 batches of fixed-dose tablets and PSs of artemether and lumefantrine. Of the samples, 23 were obtained using convenience sampling of commonly available brands within Accra in Ghana and one was obtained from Aarhus University Hospital. In all, 83.3% (confidence interval: 80-120%) passed for both artemether and lumefantrine contents, 16.7% failed by the U.S. Pharmacopoeia standards, 8.3% failed for one content, and 8.3% failed for both contents. All four products (16.7%) that failed were PSs, and two (8.3%) showed higher levels of artemether than prescribed (222% and 756%).
authors.affiliation: Department of Pharmaceutics and Microbiology, School of Pharmacy, University of Ghana, Legon, Ghana. pdebrah@ug.edu.gh.
authors.forename: Philip
authors.initials: P
authors.lastname: Debrah
authors.affiliation: Department of Pharmaceutics and Microbiology, School of Pharmacy, University of Ghana, Legon, Ghana.
authors.forename: Henry
authors.initials: H
authors.lastname: Nettey
authors.affiliation: Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus University, Skejby, Denmark.
authors.forename: Katja Kjeldgaard
authors.initials: KK
authors.lastname: Miltersen
authors.affiliation: School of Allied Health Sciences, University of Ghana, Korle-Bu, Ghana.
authors.forename: Patrick
authors.initials: P
authors.lastname: Ayeh-Kumi
authors.affiliation: Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus University, Skejby, Denmark.
authors.forename: Birgitte
authors.initials: B
authors.lastname: Brock
authors.affiliation: Department of Pharmacognosy and Herbal Medicine, School of Pharmacy, University of Ghana, Legon, Ghana.
authors.forename: Joseph Adusei
authors.initials: JA
authors.lastname: Sarkodie
authors.affiliation: Department of Pharmacy Practice and Clinical Pharmacy, School of Pharmacy, University of Ghana, Legon, Ghana.
authors.forename: Irene
authors.initials: I
authors.lastname: Akwo-Kretchy
authors.affiliation: Laboratory Services Department, Food and Drugs Authority, Cantonments, Ghana.
authors.forename: Patrick
authors.initials: P
authors.lastname: Owusu-Danso
authors.affiliation: Department of Animal Experimentation, Noguchi Memorial Institute for Medical Research, Legon, Ghana.
authors.forename: Samuel
authors.initials: S
authors.lastname: Adjei
authors.affiliation: Department of Infectious Diseases, Aarhus University Hospital, Aarhus University, Skejby, Denmark.
authors.forename: Eskild
authors.initials: E
authors.lastname: Petersen
authors.affiliation: Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus University, Skejby, Denmark.
authors.forename: Tore Forsingdal
authors.initials: TF
authors.lastname: Hardlei
mesh_terms: D000962:Antimalarials / Q000032:analysis*; D000077549:Artemether; D037621:Artemisinins / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004339:Drug Compounding; D004983:Ethanolamines / Q000032:analysis*; D005449:Fluorenes / Q000032:analysis*; D005869:Ghana; D000078102:Lumefantrine; D011208:Powders / Q000737:chemistry; D015203:Reproducibility of Results; D013607:Tablets / Q000737:chemistry
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004983:Ethanolamines; D005449:Fluorenes; D011208:Powders; D013607:Tablets; D000077549:Artemether; D000078102:Lumefantrine