Artemether–Lumefantrine Concentrations in Tablets and Powders from Ghana Measured by a New High-Performance Liquid Chromatography Method
| Autor: | Eskild Petersen, Philip Debrah, Birgitte Brock, Patrick Owusu-Danso, Henry Nettey, Samuel Adjei, Joseph Adusei Sarkodie, Tore Forsingdal Hardlei, Katja Kjeldgaard Miltersen, Irene Akwo-Kretchy, Patrick F. Ayeh-Kumi |
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| Rok vydání: | 2016 |
| Předmět: |
Validation study
Artemether/lumefantrine Drug Compounding Coefficient of variation 030231 tropical medicine Pharmacology Lumefantrine Ghana 01 natural sciences High-performance liquid chromatography Antimalarials 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Virology Journal Article medicine Artemether Chromatography High Pressure Liquid Fluorenes Drug compounding Chromatography Dose-Response Relationship Drug business.industry 010401 analytical chemistry Reproducibility of Results Articles University hospital Artemisinins 0104 chemical sciences Infectious Diseases chemistry Ethanolamines Parasitology Powders business Tablets medicine.drug |
| Zdroj: | Debrah, P, Nettey, H, Miltersen, K K, Ayeh-Kumi, P, Brock, B, Sarkodie, J A, Akwo-Kretchy, I, Owusu-Danso, P, Adjei, S, Petersen, E & Hardlei, T F 2016, ' Artemether-Lumefantrine Concentrations in Tablets and Powders from Ghana Measured by a New High-Performance Liquid Chromatography Method ', American Journal of Tropical Medicine and Hygiene, vol. 95, no. 1, pp. 158-63 . https://doi.org/10.4269/ajtmh.15-0868 |
| ISSN: | 1476-1645 0002-9637 |
| DOI: | 10.4269/ajtmh.15-0868 |
| Popis: | 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 (r2 > 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%). 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%). |
| Databáze: | OpenAIRE |
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