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The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Implications
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

Abstract.

Little is known about the quality of antibiotics despite being in high demand globally. Thirty five samples (27 brands) of the antibiotics amoxicillin ( = 20; 16 brands) and co-trimoxazole ( = 15; 11 brands), manufactured in six countries (China, Ghana, India, Ireland, Nigeria, and United Kingdom), were purchased in Ghana, Nigeria, and the United Kingdom. Their quality was assessed using German Pharma Health Fund (GPHF) MiniLab as the screening tool—two capsules of amoxicillin (10%) and two tablets of co-trimoxazole (20%) failed the thin-layer chromatography (TLC) test. Definitive drug quality was measured using high-performance liquid chromatography–photodiode array detection (HPLC-PDA) for content of the stated active pharmaceutical ingredients (APIs) and bioavailability was determined with in vitro dissolution testing. All the samples of amoxicillin complied with U.S. Pharmacopeia (USP) tolerance limits, but 60% tablets of co-trimoxazole (purchased in Ghana and Nigeria) did not. There was disparity in the results obtained for co-trimoxazole and amoxicillin samples using the MiniLab TLC tests. This highlights the need to invest in techniques such as HPLC-PDA and dissolution testing alongside the screening tests for assessing drug quality.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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2015-06-03
2017-09-26
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  • Received : 27 Aug 2014
  • Accepted : 01 Feb 2015

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