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Malaria remains one of the most devastating infectious diseases, particularly in sub-Saharan Africa, where it accounts for over 90% of global cases and deaths. Artemisinin-based combination therapies (ACTs), such as artemether-lumefantrine (AL), are the first-line treatments for uncomplicated malaria caused by Plasmodium falciparum and other resistant strains. However, the proliferation of substandard and falsified antimalarial drugs poses a significant threat to public health, undermining treatment efficacy and contributing to drug resistance. In resource-limited settings, the lack of robust, cost-effective analytical methods for drug quality assessment exacerbates this problem.

A recent study by a team of scientists at the department of Pharmaceutics, Kwame Nkrumah University of Science and Technology (KNUST) led by Simon Nyarko, undertook a study to address this critical gap by developing a novel reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous quantification of artemether and lumefantrine in fixed-dose combination (FDC) pharmaceutical dosage forms.

This groundbreaking research not only offers a rapid, precise, and cost-effective solution but also aligns with green chemistry principles, making it a sustainable choice for drug quality control in low-resource settings.

The Challenge of Substandard and Falsified Antimalarials

Substandard and falsified antimalarial drugs are a global concern, particularly in Africa and Asia, where up to 50% of medicines in circulation may be counterfeit. These drugs often contain incorrect amounts of active pharmaceutical ingredients (APIs), lack APIs entirely, or are contaminated with harmful substances. Such products can lead to treatment failures, prolonged illness, and the development of drug-resistant malaria strains, further complicating efforts to control the disease.

In Ghana, where malaria is a leading cause of morbidity and mortality, the widespread use of AL as a first-line treatment has made it a target for counterfeiters. Despite regulatory efforts, poor-quality AL formulations continue to infiltrate the market, highlighting the urgent need for reliable analytical methods to ensure drug quality.

A related study by Simon Nyarko and his team investigated the presence of falsified and poor-quality AL formulations in Kumasi, Ghana. The study evaluated 14 brands of AL formulations, including eight tablets and six suspensions, purchased from retail pharmacy outlets. While all tablet samples met the British Pharmacopoeia (BP) specifications for weight uniformity, hardness, friability, and disintegration time, two out of the six suspension brands failed the drug content assay. The artemether and lumefantrine contents in these failed suspensions ranged from 81.31% to 116.76% and 80.35% to 99.71%, respectively. These findings underscore the presence of substandard AL formulations in the Ghanaian market, particularly among suspensions, which are often used for pediatric patients.

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RELATED: Nigeria discontinues the use of key antimalarial formulation

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A Novel Solution: The RP-HPLC Method

To address the challenges posed by substandard and falsified drugs, the KNUST researchers developed a novel RP-HPLC method that simultaneously quantifies artemether and lumefantrine in pharmaceutical formulations. The method was developed using an Agilent 1260 Infinity Series HPLC system equipped with an ODS Intersil-C8 column. The mobile phase consisted of a 70:30 (v/v) mixture of acetonitrile and 0.05% orthophosphoric acid buffer (pH 3.5), with a flow rate of 1 mL/min and a column temperature of 25°C. The total run time was just six minutes, making it one of the fastest methods available for this purpose.

The method was rigorously validated according to International Council for Harmonisation (ICH) guidelines, demonstrating excellent specificity, linearity, accuracy, precision, and robustness. The calibration curves for artemether and lumefantrine showed high correlation coefficients (R² = 0.9992 and 0.9985, respectively), and the method's accuracy was confirmed by recovery studies, with recoveries ranging from 99.04% to 100.16%.

Key Findings and Implications

The study's findings highlight the importance of robust regulatory systems to ensure drug quality. The authors recommend stricter enforcement of Good Manufacturing Practices (GMPs) and strict surveillance to eliminate substandard and falsified drugs from the market. The presence of substandard and fake drugs, particularly in suspension formulations, is concerning, as these are often used to treat children, who are among the most vulnerable to malaria.

The development of this RP-HPLC method represents a significant advancement in the fight against substandard and falsified antimalarial drugs. By providing a rapid, cost-effective, and reliable means of quantifying artemether and lumefantrine in FDC formulations, the method enhances drug quality control and supports global efforts to combat malaria

Green Chemistry and Environmental friendliness

One of the standout features of this development is its alignment with green chemistry principles. The method minimizes solvent consumption, reduces waste generation, and uses environmentally friendly chemicals. This makes it not only effective but also sustainable, addressing the growing need for eco-friendly analytical methods in pharmaceutical research.

Conclusion
The development of this RP-HPLC method and the investigation into falsified and poor-quality AL formulations represent significant steps forward in the fight against malaria and substandard drugs. By providing a reliable and sustainable solution for drug quality control, this research offers hope for a future where every patient has access to safe, effective, and high-quality antimalarial drugs.

References

1. Nyarko S, Ofori-Kwakye K, Johnson R, et al. Development of the RP-HPLC method for simultaneous determination and quantification of artemether and lumefantrine in fixed-dose combination pharmaceutical dosage forms. Adv Pharmacol Pharm Sci. 2024;2024:3212298. doi:10.1155/2024/3212298.
2. Nyarko S, Ofori-Kwakye K, Johnson R, et al. Investigating the presence of falsified and poor-quality fixed-dose combination artemether-lumefantrine pharmaceutical dosage forms in Kumasi, Ghana. Adv Pharmacol Pharm Sci. 2024;2024:2650540. doi:10.1155/2024/2650540.
3. World Health Organization. Guidelines for the treatment of malaria. 3rd ed. Geneva: WHO; 2015.
4. Newton PN, Green MD, Fernández FM. Impact of poor-quality medicines in the 'developing' world. Trends Pharmacol Sci. 2010;31(3):99-101. doi:10.1016/j.tips.2009.11.005.
5. Nayyar GML, Brennan JG, Mackey TK, et al. Falsified and substandard drugs: stopping the pandemic. Am J Trop Med Hyg. 2019;100(5):1058-1065. doi:10.4269/ajtmh.18-0981.
6. Prah J, Ameyaw EO, Afoakwah R, et al. Quality assessment of artemether-lumefantrine samples and artemether injections sold in the Cape Coast Metropolis. J Trop Med. 2016;2016:8602619. doi:10.1155/2016/8602619.
7. Belew S, Suleman S, Mohammed T, et al. Quality of fixed-dose artemether/lumefantrine products in Jimma Zone, Ethiopia. Malar J. 2019;18(1):236. doi:10.1186/s12936-019-2867-0.
8. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Q2(R1): Validation of analytical procedures: text and methodology. Geneva: ICH; 2005

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About the Author

Simon Nyarko is a pharmaceutical scientist, lecturer, and a freelance science communicator with a Master of Philosophy (M.Phil.) in Pharmaceutics and a strong focus on pharmacoepidemiology, antimicrobial resistance, drug pricing, drug policy and politics, one health and drug quality assessment. He has authored and published quality research findings and has presented his research at international conferences, including the Pan-Africa Malaria Conference and the International Conference on Public Health in Africa. Simon is also a trained science journalist and a fellow of Science Journalism Ghana, where he contributes to public health discourse through science communication.

In addition to his research and teaching, Simon is actively involved in community engagement and leadership, serving as Deputy Ambassador for SynBio Africa and volunteering with organizations focused on healthcare and education. His work bridges the gap between pharmaceutical science, public health, and community development, making a significant impact on healthcare outcomes in Africa.

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The African Pharmaceutical Review editorial staff had no role in this post's creation.

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