Abstract
A recently developed semiquantitative thin-layer chromatographic (SQ-TLC) assay has been employed in postmarketing surveillance of antimalarial medicines used in Malawi prior to HPLC assay. Both methods gave analogous results in a significant majority of the samples, with a good correlation (r = 0.9012) for the active pharmaceutical ingredients of the dosage forms assayed. Artemether-containing medicines had the highest percentage (92.67%) of samples with comparable results for both assays. The lowest percentage (66.67%) was observed in artesunate-containing medicines. The SQ-TLC method was validated for specificity, accuracy, precision, linearity, and stability according to the International Conference on Harmonisation guidelines, with the results falling within acceptable limits. For specificity, retention factor values of the test samples and reference standards were comparable, while accuracy and precision of 91.1 ± 5.7% were obtained for all samples. The method was linear in the range 1.0–2.0 µg/spot with a correlation coefficient of r = 0.9783. Stability tests also fell within acceptable limits. In this study, we present the validation of the SQ-TLC method and propose its adoption as a rapid screening tool for field estimation of the quality of antimalarial and other essential medicines in Malawi and other parts of the developing world prior to a more accurate HPLC assay.
Highlights
Developing countries continue to be a suitable hub for pharmaceutical counterfeiting due to poor policing and postmarketing surveillance of pharmaceuticals. is practice jeopardises public health efforts in ameliorating disease burden on populations
As part of efforts to boost the regulatory activities to the required scale and frequency, we present the semiquantitative thin-layer chromatographic (SQ-to resistance. in-layer chromatography (TLC)) method and recommend its adoption in both field and laboratory evaluation of the quality of essential medicines used in Malawi
To check the effectiveness of the extraction, another 2 mL of the solvent was added to the residue and a TLC spot developed from the subsequent filtrate alongside the reference standard. e absence of a spot from this filtrate suggested complete active pharmaceutical ingredients (APIs) extraction
Summary
Developing countries continue to be a suitable hub for pharmaceutical counterfeiting due to poor policing and postmarketing surveillance of pharmaceuticals. is practice jeopardises public health efforts in ameliorating disease burden on populations. Regardless of the superiority of high-performance liquid chromatography (HPLC), TLC continues to be a mandatory identification and purity test in pharmaceutical analysis It has been successfully employed as a simple, robust, and cheap method for providing product quality assessments including the identification of substances resulting from degradation as well as the detection of counterfeit and subtherapeutic concentrations of essential medicines [1,2,3,4,5]. Many of the interventions proposed and deployed to mitigate this problem through the support of the World Health Organization (WHO) and other international organisations in resource-constrained settings are TLC-based One such prominent initiative is the Global Pharma Health Fund (GPHF) Minilab which contains consistent, cheap, and simple methods for the prompt detection of counterfeit and substandard medicines for tuberculosis, malaria, and Journal of Analytical Methods in Chemistry. E method is useful for rapid and reliable estimation of the quality of antimalarial drugs prior to a more accurate HPLC assay and has been successfully employed in two surveys in Ghana and Togo sponsored by the WHO and the West African Health Organization (WAHO) [8, 9]
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