Quantitative determination of active pharmaceutical ingredient and trace elements in ciprofloxacin tablets distributed in Lagos State, Nigeria

Background: Substandard ciprofloxacin with low or very high concentrations of the active ingredients are injurious to health and may be responsible for drug bacterial resistance and failure of therapeutic functions. This study attempt to assess the physicochemical quality/concentration of the active ingredient in some brands of Ciprofloxacin consumed in Lagos.

Methods: Analysis of weight uniformity, friability, hardness and disintegration were performed using standard methods. Determinations of the concentration of active pharmaceutical ingredient and heavy metals in ciprofloxacin tablets were done using high performance liquid chromatography techniques (HPLC) and atomic absorption spectrophotometer (AAS) respectively.

Results: Of content uniformity revealed that the weight of twenty samples of ciprofloxacin were within the compendia specification for content uniformity. The disintegration rate ranged from 3 to 6 minutes and was within the allowable limits of not more than 15 minutes. The mean hardness and friability of all the brands complied with the standard specification for hardness (not less than 20N) and friability (not more than 1%) respectively. The assay results of ciprofloxacin samples ranged from 96. 8% - 106.1% with a relative standard deviation of 0.2%. The concentration of ciprofloxacin in analyte samples were within the recommended specifications range of 90.0% - 110.0% and within the maximum allowable standard deviation of 1.5%. The heavy metals concentrations were within the permissible limit of not more 20 ppm in ciprofloxacin tablets.

Conclusion: The results of this study revealed that the ten brands of ciprofloxacin complied with the standard recommended limits and were fit for their therapeutic functions.