Abstract

This research provided quantitative data for the quality of randomly selected ibuprofen tablets that are sold in both formal and informal market in Harare, Zimbabwe. Fourteen batches of ibuprofen tablets comprising of sixty tablets per batch were randomly selected from retail pharmacies and informal traders over a period of six months. Quality control tests which included physical appearance, uniformity of mass, disintegration test, friability, in vitro dissolution test, spectrophotometric and High Performance Liquid Chromatography (HPLC) profiling of the samples were carried out. Three out of the fourteen batches failed the uniformity of mass test. Those that failed were from the informal market. One out of these also failed the quantitative chemical assay and dissolution test. Four other ibuprofen batches were according to labelling from the same manufacturer but had differences in the packaging used therefore raising suspicion of the possibility of counterfeiting. Two more ibuprofen samples were from the same manufacturer but the appearance of these samples differed in shape size and colour and therefore failed the appearance test. The other batches passed all the tests done. All the samples tested contained the stated active pharmaceutical ingredient (API), ibuprofen. However, the other three samples were reported as substandard as they failed to meet the WHO set standards for either uniformity of weight, chemical assay test or dissolution test.

Key words: Ibuprofen, quality counterfeit, active pharmaceutical ingredient (API), friability, high performance liquid chromatography (HPLC), Fourier transform infrared spectroscopy (FTIR).