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Use of thin-layer chromatography to detect counterfeit sulfadoxine/pyrimethamine tablets with the wrong active ingredient in Malawi.
Malar J. 2016 Apr 14; 15:215.MJ

Abstract

BACKGROUND

Substandard and falsified anti-malarial medicines pose a serious threat to public health, especially in low-income countries. Appropriate technologies for drug quality analysis in resource-limited settings are important for the surveillance of the formal and informal drug market. The feasibility of thin-layer chromatography (TLC) with different solvent systems was tested using the GPHF Minilab in a study of the quality of sulfadoxine/pyrimethamine tablets in Malawi.

METHODS

Twenty eight samples of sulfadoxine/pyrimethamine tablets were collected from randomly selected health facilities of four districts of southern Malawi. A mystery shopper approach was used when collecting samples from illegal street vendors, and an overt approach for the other facilities. Samples were subjected to visual inspection, disintegration testing and TLC analysis. 10 samples were further investigated according to the methods of the US Pharmacopeia using high performance liquid chromatography (HPLC).

RESULTS

One sample was found to be falsified, containing a mixture of paracetamol tablets and co-trimoxazole tablets. These had been repackaged into paper strip packs labelled as a brand of sulfadoxine/pyrimethamine. TLC with different solvent systems readily proved that these tablets did not comply with their declaration, and provided strong evidence for the active pharmaceutical ingredients which were actually contained. Full pharmacopeial analysis by HPLC confirmed the results suggested by TLC for this sample, and showed two further samples to be of substandard quality.

CONCLUSIONS

Due to the absence of the declared anti-malarial ingredients and due to the presence of other pharmaceutical ingredients, the identified falsified medicine represents a serious health risk for the population. Thin-layer chromatography (TLC) using different solvent systems proved to be a powerful method for the identification of this type of counterfeiting, presenting a simple and affordable technology for use in resource-limited settings.

Authors+Show Affiliations

Pharmacy Department, College of Medicine, University of Malawi, Private Bag 360, Chichiri, Blantyre 3, Malawi.Mission for Essential Drugs and Supplies (MEDS), P.O. Box 78040-00507, Viwandani, Nairobi, Kenya.Global Pharma Health Fund e.V. (GPHF), Rotlintstraβe 75, 60389, Frankfurt, Germany.Pharmacy Department, College of Medicine, University of Malawi, Private Bag 360, Chichiri, Blantyre 3, Malawi. heide@uni-tuebingen.de. Presented address: Pharmaceutical Institute, Eberhard-Karls-University Tuebingen, Auf der Morgenstelle 8, 72076, Tuebingen, Germany. heide@uni-tuebingen.de.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27075749

Citation

Khuluza, Felix, et al. "Use of Thin-layer Chromatography to Detect Counterfeit Sulfadoxine/pyrimethamine Tablets With the Wrong Active Ingredient in Malawi." Malaria Journal, vol. 15, 2016, p. 215.
Khuluza F, Kigera S, Jähnke RW, et al. Use of thin-layer chromatography to detect counterfeit sulfadoxine/pyrimethamine tablets with the wrong active ingredient in Malawi. Malar J. 2016;15:215.
Khuluza, F., Kigera, S., Jähnke, R. W., & Heide, L. (2016). Use of thin-layer chromatography to detect counterfeit sulfadoxine/pyrimethamine tablets with the wrong active ingredient in Malawi. Malaria Journal, 15, 215. https://doi.org/10.1186/s12936-016-1259-9
Khuluza F, et al. Use of Thin-layer Chromatography to Detect Counterfeit Sulfadoxine/pyrimethamine Tablets With the Wrong Active Ingredient in Malawi. Malar J. 2016 Apr 14;15:215. PubMed PMID: 27075749.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Use of thin-layer chromatography to detect counterfeit sulfadoxine/pyrimethamine tablets with the wrong active ingredient in Malawi. AU - Khuluza,Felix, AU - Kigera,Stephen, AU - Jähnke,Richard W O, AU - Heide,Lutz, Y1 - 2016/04/14/ PY - 2015/12/17/received PY - 2016/03/31/accepted PY - 2016/4/15/entrez PY - 2016/4/15/pubmed PY - 2016/12/21/medline KW - Falsified medicines KW - GPHF Minilab KW - SSFFC medicinal products KW - Sulfadoxine/pyrimethamine KW - Thin-layer chromatography SP - 215 EP - 215 JF - Malaria journal JO - Malar J VL - 15 N2 - BACKGROUND: Substandard and falsified anti-malarial medicines pose a serious threat to public health, especially in low-income countries. Appropriate technologies for drug quality analysis in resource-limited settings are important for the surveillance of the formal and informal drug market. The feasibility of thin-layer chromatography (TLC) with different solvent systems was tested using the GPHF Minilab in a study of the quality of sulfadoxine/pyrimethamine tablets in Malawi. METHODS: Twenty eight samples of sulfadoxine/pyrimethamine tablets were collected from randomly selected health facilities of four districts of southern Malawi. A mystery shopper approach was used when collecting samples from illegal street vendors, and an overt approach for the other facilities. Samples were subjected to visual inspection, disintegration testing and TLC analysis. 10 samples were further investigated according to the methods of the US Pharmacopeia using high performance liquid chromatography (HPLC). RESULTS: One sample was found to be falsified, containing a mixture of paracetamol tablets and co-trimoxazole tablets. These had been repackaged into paper strip packs labelled as a brand of sulfadoxine/pyrimethamine. TLC with different solvent systems readily proved that these tablets did not comply with their declaration, and provided strong evidence for the active pharmaceutical ingredients which were actually contained. Full pharmacopeial analysis by HPLC confirmed the results suggested by TLC for this sample, and showed two further samples to be of substandard quality. CONCLUSIONS: Due to the absence of the declared anti-malarial ingredients and due to the presence of other pharmaceutical ingredients, the identified falsified medicine represents a serious health risk for the population. Thin-layer chromatography (TLC) using different solvent systems proved to be a powerful method for the identification of this type of counterfeiting, presenting a simple and affordable technology for use in resource-limited settings. SN - 1475-2875 UR - https://www.unboundmedicine.com/medline/citation/27075749/Use_of_thin_layer_chromatography_to_detect_counterfeit_sulfadoxine/pyrimethamine_tablets_with_the_wrong_active_ingredient_in_Malawi_ L2 - https://malariajournal.biomedcentral.com/articles/10.1186/s12936-016-1259-9 DB - PRIME DP - Unbound Medicine ER -