COMPARATIVE STUDY OF SEVEN BRANDS OF LEVOFLOXACIN 500 MG FILM COATED TABLET MARKETED IN YEMEN
Objective: The objective of the current study was to evaluate the quality control parameters of seven brands of levofloxacin 500 mg film-coated tablet available in the Yemeni market.
Methods: Physicochemical parameters assay was performed for seven brands of levofloxacin 500 mg film-coated tablet. Each brand was subjected to official and unofficial in vitro quality control tests, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity assay by High Performance Liquid Chromatography (HPLC).
Results: Out of seven, six brands of levofloxacin 500 mg film-coated tablets passed all the official specified assay tests according to the United States Pharmacopeia (USP) specifications. All studied brands showed a similar profile of content uniformity, thickness, friability, and disintegration, as well as dissolution percentage with greater than 90%. Only one brand failed to pass weight variation test, and four brands failed to pass the optimum range (10-20 kg) of hardness.
Conclusion: This study concluded that there are no remarkable differences between the seven brands of levofloxacin 500 mg film-coated tablets regarding in-vitro quality control tests of content uniformity, thickness, friability, disintegration, and dissolution; however, only one brand failed to pass weight uniformity test. Even though four brands were above the optimum range of hardiness, they showed complete disintegration and dissolution within the acceptable limit of USP standards. Almost all seven brands exhibited similar quality control standards and thus efficiency. Regular assessment of marketed drug is required to ensure bioequivalent to their innovators.
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