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Keywords

Bioequivalence
dissolution
disintegration
frusemide
quality control

Abstract

Objective: To evaluate the chemical and biopharmaceutical equivalence of frusemide tablets from ٥ different companies. Methods: This study was conducted on five brands of frusemide tablets available in the pharmacies of Mosul city from different manufacturing companies. These brands have been evaluated using some quality control tests of uniformity of weight, hardness, disintegration time, dissolution rate determination for the tablets. Results: The results obtained have been discussed in some detail using monographs in the United State Pharmacopeia (USP) and British Pharmacopeia (BP). All the brands content were within the acceptable range of USP (٩٠-١١٠ %), the disintegration time of all the brands also within the range of the USP and BP. . The dissolution profile also were within the acceptable range of USP not less than ٨٠% of the labeled amount of frusemide is dissolved in ٦٠ minutes. Conclusion: All the brands tested in this study may be used interchangeably.
https://doi.org/10.33899/iphr.2011.49573
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