ISSN 2326-7267
International Journal of Pharmacy and Pharmacology ISSN: 2326-7267 Vol. 2 (10), pp. 001-006, October, 2011. © International Scholars Journals
Full Length Research Paper
Pilot study comparing technologies to test for substandard drugs in field settings
Roger Bate1, 2*, Richard Tren2,3, Kimberly Hess2, Lorraine Mooney4 and Karen Porter1
1American Enterprise Institute, 1150 Seventeenth Street, NW, Washington, DC 20036, USA.
2Africa Fighting Malaria, 1050 Seventeenth Street, NW, Suite 590, Washington, DC 20036, USA.
3Africa Fighting Malaria, P. O. Box 17156 Congella, 4013, South Africa.
4Africa Fighting Malaria, 4 Church Lane, Barton, Cambridge, CB3 7BE, UK.
Accepted 13 March, 2011
Abstract
Researchers procured a range of antimalarial, antibiotic and antimycobacterial drugs from cities in six countries: Ghana, India, Kenya, Nigeria, Tanzania, and Uganda. Semi-quantitative thin-layer chromato-graphy (TLC) and disintegration tests, Raman spectrometry, and near-infrared (NIR) spectrometry were used to measure the concentration of active ingredients and excipients (spectrometry only) to deter-mine whether the tested samples were of good quality. Overall, 15% of tested samples failed TLC, 13% of tested samples failed disintegration tests, 41% of tested samples failed NIR spectrometry, and 47% of tested samples failed Raman spectrometry. The drug testing technologies were qualitatively compared in terms of time, cost, and reliability for identifying substandard drugs in the field. NIR and Raman spectrometry compared favorably to TLC in most respects except cost. If the indirect costs of TLC— including requirements for a climate controlled location and trained laboratory staff—are considered, the cost advantage of TLC may disappear in developing countries.
Key words: Raman and near-infrared spectrometry, thin-layer chromatography, counterfeit and substandard drug production, regulation of drug quality.