Evidence map›Paper›PMID 27139437›Full record

ArticleThe American journal of tropical medicine and hygiene2016

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

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 and 1 more

Abstract readValidation Study
In one paragraph

Article in The American journal of tropical medicine and hygiene, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Philip DebrahDepartment of Pharmaceutics and Microbiology, School of Pharmacy, University of Ghana, Legon, Ghana. pdebrah@ug.edu.gh.
Henry NetteyDepartment of Pharmaceutics and Microbiology, School of Pharmacy, University of Ghana, Legon, Ghana.
Katja Kjeldgaard MiltersenDepartment of Clinical Biochemistry, Aarhus University Hospital, Aarhus University, Skejby, Denmark.
Patrick Ayeh-KumiSchool of Allied Health Sciences, University of Ghana, Korle-Bu, Ghana.
Birgitte BrockDepartment of Clinical Biochemistry, Aarhus University Hospital, Aarhus University, Skejby, Denmark.
Joseph Adusei SarkodieDepartment of Pharmacognosy and Herbal Medicine, School of Pharmacy, University of Ghana, Legon, Ghana.
Irene Akwo-KretchyDepartment of Pharmacy Practice and Clinical Pharmacy, School of Pharmacy, University of Ghana, Legon, Ghana.
Patrick Owusu-DansoLaboratory Services Department, Food and Drugs Authority, Cantonments, Ghana.
Samuel AdjeiDepartment of Animal Experimentation, Noguchi Memorial Institute for Medical Research, Legon, Ghana.
Eskild PetersenDepartment of Infectious Diseases, Aarhus University Hospital, Aarhus University, Skejby, Denmark.
Tore Forsingdal HardleiDepartment of Clinical Biochemistry, Aarhus University Hospital, Aarhus University, Skejby, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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%).

Indexed as

AntimalarialsArtemetherArtemisininsChromatography, High Pressure LiquidDose-Response Relationship, DrugDrug CompoundingEthanolaminesFluorenesGhanaLumefantrinePowdersReproducibility of ResultsTabletsAntimalarialsArtemetherArtemisininsEthanolaminesFluorenesLumefantrinePowdersTablets

Identifiers

PMID27139437
PMCPMC4944682

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.