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Abstract

This study assesses the quality of Artemether-Lumefantrine tablet brands in Ghana, highlighting the risks posed by fake drugs amidst a significant malaria crisis. While all brands met FDA packaging and labeling requirements, two samples failed to meet the active ingredient composition standards in UV analysis, although HPLC results indicated compliance with pharmacopeial requirements. The findings emphasize the need for ongoing quality evaluations of antimalarial drugs to ensure public safety.

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Caleb Asharley
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6 views1 page

Abstract

This study assesses the quality of Artemether-Lumefantrine tablet brands in Ghana, highlighting the risks posed by fake drugs amidst a significant malaria crisis. While all brands met FDA packaging and labeling requirements, two samples failed to meet the active ingredient composition standards in UV analysis, although HPLC results indicated compliance with pharmacopeial requirements. The findings emphasize the need for ongoing quality evaluations of antimalarial drugs to ensure public safety.

Uploaded by

Caleb Asharley
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Abstract

Background: The proliferation of fake drugs in Ghana has severely undermined the
credibility of the healthcare system and poses significant risks to consumers, including
illness, disability, and even death dangers that no one is immune to. Malaria, a major public
health issue in Ghana, is responsible for an estimated 11,557 deaths annually. The
Artemether-Lumefantrine combination is the first-line artemisinin-based therapy (ACT)
recommended by the World Health Organization (WHO) for treating malaria. This study
evaluated the quality of various Artemether-Lumefantrine tablet brands to determine whether
they contain the level of active ingredients stated on their labels and whether they meet the
specified pharmacopeial requirements. The study also analysed the percentage content of
these brands using the HPLC-UV method.

Method: Physical assessment studies, pharmacopoeia test (weight uniformity USP, UV and
TLC) and non-pharmacopeial tests; (hardness, disintegration, friability and FT-IR) were
carried out, and the percentage content of the active ingredients were obtained using the UV
and HPLC-UV method.

Result: The physical assessment tests showed that all artemether-lumefantrine brands
conformed to FDA stipulations for packaging and labelling. All the brands passed the weight
uniformity, disintegration, friability and TLC tests, with only one of the sampled brands
(sample B) failing the hardness test. An assay of active ingredients using UV analysis of
lumefantrine showed that two samples (samples A and B) failed with percentage composition
of lumefantrine of 89.866% and 78.821% respectively. HPLC showed that all samples met
the International Pharmacopeial percentage content requirement of 90% - 110% for both
Artemether and Lumefantrine.

Conclusion: The importance of regularly evaluating the quality of antimalarial drugs


available to the public cannot be overstated, as it is crucial for ensuring safety.

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