Vol. 3, Issue 7, Part K (2017)

Abstract
Quality of pharmaceutical products is very important because drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. The evaluation of the physical characteristics of the pharmaceutical products can ensure their quality as well as bioavailability and impart optimum therapeutic activity. Metronidazole was chosen for this comparative study because this drug is widely used worldwide in the treatment of amoebiasis and other microbial diseases. Studies on metronidazole revealed that it is a recommended treatment during pregnancy for infections with bacterial vaginitis and Trichomonas vaginalis. The purpose of this study was to compare the quality of metronidazole tablets of some brands and to evaluate whether all brands obey the USP protocols. There are many different brands and different types of dosage forms of metronidazole under various trade names manufactured by different pharmaceutical companies available in the market. For this current research work nine brands (brand codes M1, M2, M3, M4, M5, M6, M7, M8, M9) of metronidazole film coated tablets (400mg) commercially available in Bangladesh were collected and evaluation studies were conducted which includes diameter and thickness measurement, weight variation test, friability test, hardness test, disintegration time, dissolution profile, and potency determination. Tests were performed as per the method described in United States of Pharmacopoeia (USP). All brands were found to comply with the USP specifications. According to this analysis, minimum weight variation was found in brand M4. Brand M9 showed the highest average hardness of 298.33N with minimum disintegration time (2.32 minutes) and highest friability (0.42%) among other brands. The lowest friability was 0.02% with brand M1.The highest potency was 104.09% (brand M7) and all the brands showed active drug release within ±5% of label amount. Dissolution pattern and potency of the metronidazole tablets were determined by the UV spectroscopic method at 278nm in the acidic (0.1N HCl) medium. All brands showed satisfactory dissolution profile as they released more than 85% drug in 60 minutes. Among these brands M4 showed highest drug release at required time interval. Dissolution profile of brand M1, M5 and M6 were found similar to that of brand M4 by comparing difference factor (f₁) and similarity factor (f₂) values of all nine brands. For better therapeutic effects and safe use of drugs, quality parameters should be maintained strictly.