ArticleMalaria journal2020
Development of a dissolution method for lumefantrine and artemether in immediate release fixed dose artemether/lumefantrine tablets.
Article in Malaria journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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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.
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Who cites it
5 citing papers in PubMed, 9 citations in OpenAlex.
- Green Chiral HPLC Method for Lumefantrine Analysis: Method Development, Greenness Assessment, and Computational Studies.Chirality · 2026Article
- Ligand decorated nanostructure carrier systems for targeted delivery of antimalarials.Discover nano · 2026Review
- Quality assessment of oral antimalarial and antiretroviral medicines used by public health systems in Sahel countries.PloS one · 2024Article
- Discriminative Dissolution Method Development Through an aQbD Approach.AAPS PharmSciTech · 2023Article
- Orally Deliverable Dual-Targeted Pellets for the Synergistic Treatment of Ulcerative Colitis.Drug design, development and therapy · 2021Article
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDissolution of artemether (ART) and lumefantrine (LUM) active pharmaceutical ingredients (APIs) in fixed dose combination (FDC) ART/LUM tablets is one of the critical quality attributes. Thus, the verification of the release profile of ART and LUM from FDC ART/LUM tablets using a robust and discriminatory dissolution method is crucial. Therefore, the aim of this study was to develop and validate an appropriate dissolution method for quality control of FDC ART/LUM tablets.
methodsThe dissolution medium was selected based on saturation solubility data and sink conditions. The effect of agitation speed, pH and surfactant concentration on the release of ART and LUM was evaluated by employing a two-level factorial experiment. The resulting final method was validated for linearity, precision, robustness and API stability. In addition, the discriminatory power of the method was evaluated using expired and unexpired FDC ART/LUM products.
resultsA suitable dissolution profile of FDC ART/LUM tablets was obtained in 900 ml HCl (0.025 N, pH 1.6) with 1%Myrj 52 using paddle method at 100 rpm and 37 °C. ART and LUM were analysed using a HPLC method with UV detection at wavelengths of 210 and 335 nm, respectively. The results from the stability study showed that ART and LUM were sufficiently stable in HCl (0.025 N, pH 1.6) with 1%Myrj 52 at 37 °C. The method was linear (r
conclusionsThe developed dissolution method is robust and discriminatory. It can be used in the quality evaluation of FDC ART/LUM tablets.
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Registered trials
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