Bioequivalence & Bioavailability International Journal (BEBA)

ISSN: 2578-4803

Research Article

Physicochemical and In-Vitro Bioequivalence Analysis of Some Oral Solid-Dosage Metronidazole Formulations

Authors: Bunu SJ*, Kpun FH, Obasi FC, Kashimawo AJ, Vaikosen EN and Ebeshi BU

DOI: 10.23880/beba-16000221

Abstract

Background: Metrodidazole is a 5-nitroimidazole antimicrobial agent, widely used in the treatment of infections caused by Trichomonas vaginalis, such as trichomoniasis, pseudomembranous colitis, and symptomatic amoebiasis resulting from anaerobic bacteria. Aim: The study aimed to qualitatively determine the quality and in-vitrobioequivalence of selected brands of metronidazole tablet dosage forms used in the management of infectious diseases. Method: The British Pharmacopeia (BP) Standard methods were followed to conduct weight uniformity, disintegration time, hardness, and friability tests. For the Thin Layer Chromatographic (TLC) Fingerprinting, 0.1g of the brands were weighed and dissolved ins 50 ml methanol (50%). The stock solution was prepared using 50% methanol and 50% dichloromethane and was transferred into the Chamber and allowed to stand for about 45 minutes; the plates were viewed under UV-VIS Spectrophotometer at 365 nm. Result: All the brands complied with the acceptable friability limit, and disintegrated within the appropriate time of not more than 15 minutes as specified in BP, for uncoated tablets. The tablets were found to have a dissolution profile of at least 70% of the active ingredient taken at 45 minutes from the dissolution medium as stated in BP. The analysis showed the consistency of concentration of the selected tablet brands with the label claims. Conclusion: The TLC procedure used in the analysis was accurate and precise, no interference was observed from the excipients. Thus, this method can be used in the routine quality control of metronidazole solid dosage form.

Keywords: Thin-Layer Chromatography; Metronidazole; Nitroimidazole; Antibiotics; Anti-Infective

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