Quality assessment of various brands of Levofloxacin tablets available in Uyo Metropolis
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Abstract
Levofloxacin is a second-generation fluoroquinolone antibacterial agent used for the treatment of a variety of bacterial infections, especially urinary tract infections, and prostitis. Ten brands of levofloxacin were sourced from various pharmacies in Uyo metropolis and subjected to qualitative and quantitative assay using standard physical tests and spectrophotometric method respectively. The standard physical tests done were weight uniformity, hardness, friability, disintegration and dissolution rate. Quantitative assay was by a spectrophotometric measurement of the ion-pair complex of the drug with the sulphonpthalein dye, bromothymol blue (BTB), using chloroform as the solvent. All the brands met the standard for weight uniformity test as they had percentage deviation of less than 5%. All the brands failed the hardness test as they had crushing strength of more than 10Kg/cm2. All brands met the standard for friability test and disintegration test as they had percentage weight losses of less than 1% (w/w) and they all disintegrated in less than 15 minutes. Two brands did not meet the requirement for dissolution rate as they had less than 80% of the drug dissolving in 30 minutes. The spectrophotometric measurement was done at 410mn. The calibration curve for reference levofloxacin was linear over a concentration range of 2.5-40?g/mL and the recovery of the drug ranged between 99.04-100.09%. The ten brands were within the limits specified in the official compendia. The results obtained from these tests gave important information on the standard and batch-to-batch consistency of the evaluated brands. The spectrophotometric assay method is simple and precise for the analysis of levofloxacin in bulk and pharmaceutical dosage forms.
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