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Udgivet

Artemether-Lumefantrine Concentrations in Tablets and Powders from Ghana Measured by a New High-Performance Liquid Chromatography Method

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  • Philip Debrah
  • Henry Nettey
  • Katja Kjeldgaard Miltersen
  • Patrick Ayeh-Kumi
  • Birgitte Brock
  • Joseph Adusei Sarkodie
  • Irene Akwo-Kretchy
  • Patrick Owusu-Danso
  • Samuel Adjei
  • Eskild Petersen
  • Tore Forsingdal Hardlei
Vis graf over relationer

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%).

OriginalsprogEngelsk
TidsskriftThe American journal of tropical medicine and hygiene
Vol/bind95
Udgave nummer1
Sider (fra-til)158-63
Antal sider6
ISSN0002-9637
DOI
StatusUdgivet - 6 jul. 2016
Eksternt udgivetJa

ID: 51419085