Simple screen detects fake and substandard antibiotics

Question mark tablets in blisterScientists have devised simple screening technique for 19 of the most commonly-used antibiotics that could help in the fight against counterfeit, substandard and degraded medicines.

The researchers from Belgium, Rwanda and the Democratic Republic of Congo (DRC) say they devised the ultra-high-throughput liquid chromatography (UHPC) assay to pick up antibiotics most targeted by counterfeiters, including ceftriaxone, ciprofloxacin, metronidazole, sulbactam, amoxicillin and tetracycline.

The validated method was then used to analyse two antibiotics marketed in the DRC (sulbactam and ceftriaxone) that are often targeted by counterfeiters, and found two out-of-specification (OOS) results out of three products tested.

The objective was to provide a generic but robust method that can be used to "trace, screen and determine" antibiotics rapidly and with minimal use of consumables such as solvents.

It was developed using an approach in pharmaceuticals known as 'design space', part of the Quality by Design (QbD) concept laid out in the International Conference of Harmonization (ICH) Q8 guideline on pharmaceutical development.

The test was designed to be robust despite variations in the temperature, the gradient time and the pH, making it suitable for reliable deployment in quality control laboratories around the world.

"The poor quality of medicines is a crucial problem of public health," write the authors of the study, which is published in the Journal of Pharmaceutical and Biomedical Analysis (November 2013 edition).

Counterfeiting flourishes in developing countries because of a lack of controls at importation as well as insufficient quality control of medicinal products at different levels of the distribution chain including import, wholesalers, official and informal vendors, they add.

"It is important to have analytical tools to attend decisions of the legal authorities while combating this offense."

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