| Abstrakt: |
Metronidazole (2-methyl-5-nitroimidazole-1-ethanol) is a synthetic antibacterial and antiprotosoal agent of the nitroimidazole drugs. It shows high activity against Trichomonas vaginalis and Entamoeba hystolitica. The objective of this paper is the pharmaceutical analysis of solid oral formulations (9 tablets) containing metronidazole available on the market of Bosnia and Herzegovina. The following process parameters were studied: appearance, average tablet weight, disintegration, content uniformity, dissolution test, assay determination of metronidazole and related substances. The appearance, mass balance, disintegration, content complied with the quality requirement according to European pharmacopoeia. Metronidazole content in all tested samples was within the limits of the shelf-life specification (102.00%, 95.70%, 94.81%, 95.00%, 107.56%, 98.40%, 90.65%, 96.22%, 98.12%), as well as the results of dissolution test (Tolerances: NLT 80%(Q) of the labeled amount is dissolved). Related substances in all tested samples were within the limits of the shelf-life specification (Tinidazole related substance A <0.5%, any individual unspecified degradation product <0.10%, Total impurities <2.0%). The results of the research have shown that all tested samples purchased on the market of Bosnia and Herzegovina correspond to specified quality requirements with official pharmacopoeias monographs (BP and USP Metronidazole Tablets) [ABSTRACT FROM AUTHOR] |
