Comparative assessment of the quality control measurements of multisource ofloxacin tablets marketed in Nigeria

Abstract

This study aimed at evaluating some quality control parameters to compare the quality, safety, and efficacy of nine brands of ofloxacin tablets available in the Nigerian market. The physicochemical parameters and assay of the nine brands of ofloxacin tablets were assessed through the evaluation of uniformity of tablet weight, friability, hardness, disintegration, and assay of active ingredients according to established methods. The dissolution rate and disintegration time were determined in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) without enzymes. The concepts of dissolution efficiency (DE) and predicted availability equivalence (PAE) were used to estimate the likely in vivo bioavailability. All brands complied with the official specification for uniformity of weight, friability, and disintegration. The disintegration test revealed that the drugs had higher disintegration times in SGF (7.0 ± 0.95) relative to those in SIF (5.0 ± 2.55). The dissolution profiles in SGF showed that only one sample attained 70% dissolution in less than 45 min and the other 5 samples in 1 h, while in SIF, four samples attained 70% dissolution in 45 min and all samples in 1 h. The UV spectrophotometric assay of ofloxacin tablets revealed that three samples contained over 95% (w/w) of labeled chemical content. The PAE in SGF indicated over 90% release from five samples, while it revealed over 70% release in SIF from three samples out of the aforementioned. Only four of the brands considered in this study demonstrated comparable quality standards. The method is simple and rugged for both routine analysis and evaluation of the dissolution pattern of ofloxacin tablets as in vitro tests for batch-to-batch quality control assessment.