Quality assessment of ten brands of ofloxacin tablets marketed in Lagos, Nigeria
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Abstract
Background: Ofloxacin is a synthetic chemotherapeutic agent used to treat severe and life threatening infections. It is a fluoroquinolone antibiotic with broad spectrum of activity.
Objectives: This study is aimed at evaluating some physicochemical parameters and assay of ten different brands of ofloxacin 200 mg tablets sourced from various pharmaceutical stores in Lagos.
Methods: The physicochemical tests carried out include uniformity of weight, hardness, friability, disintegration and dissolution tests according to the BP and USP established methods. The quantitative assay was carried out using the UV/visible spectrophotometry. Similarity factor (f2) was used to assess the dissolution profile among the brands.
Results: The results indicated that all brands complied with the official specification for uniformity of weight, friability, and disintegration. However, the dissolution profiles in 0.1N HCl showed that only one brand (OFLO- 6) failed to attain 80% dissolution in 30 min, although it passed quantitative assay test. The quantitative assay showed that two brands (OFLO-2 and OFLO-7) contained less than 90% of labeled ofloxacin content. OFLO-6, OFLO-7 and OFLO-10 brands showed dissimilarity in dissolution profile relative to the innovator brand (OFLO- 1), thus may not be used interchangeably within clinical considerations.
Conclusion: The result shows that chemical equivalence does not indicate bioequivalence. Owing to the vast influx of pharmaceuticals into the Nigeria drug market, it is important that regulatory agencies engage in periodic post-marketing analytical quality assessment.
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