Abstract
Metronidazole is a commonly used drug. It has an activity against protozoa and anaerobic bacteria. The success of drug therapy using this drug and others depends, among other factors, on the quality of the product. The aim of this study is to assess the quality of different brands of metronidazole tablets and to test their stability after storage. The three brands used were SupplineR (Sp) of Biochemie, Austria; Metronidazole (Mnz) of Life pharma, Italy; and FlagylR (Fg) of Specia Rhome Poulene Rorer, France. The objectives were achieved by carrying out the following tests: weight variation, crushing strength, friability, and disintegration tests according to the BP methods and the content uniformity and the assay using the USP methods. The results of this study showed that the three brands met the official requirements. The results of the assay test showed that Sp, Mnz, and Fg tablets had 95.3%, 98.6%, and 104.3% of labeled amount of the active ingredient respectively. The three products passed and met the official requirements of the physicochemical tests. Storage was found to have an effect on the disintegration time. The disintegration time before and after storage for Mnz tablets was 43.3s (SD +/- 7.6) and 414.8s (SD +/- 101.8) and for Sp was 51.6s (SD +/- 18.2) and 77.0s (SD +/- 53.9) respectively. The differences between the three brands may be due to the differences in formulations, manufacturing process and conditions, nature and/or the thickness of film coat. From the result of this study we can conclude that: (a) the three brands of metronidazole tablet had good quality and met the official requirements but they had different disintegration time; and (b) storage has an effect on the chemical stability of the drug and on the disintegration time. Keywords: Metronidazole tablets, SupplineR, FlagylR, MetronidazoleR, evaluation, disintegration, content uniformity, and stability.