Comparative Assessment of the Q/C Measurements of Ofloxacin Tablets : Introduction, Concept, Methods And Results

Bok av Dinesh Babu
The main purpose of the study is to evaluate some quality control parameters to compare the quality, safety, and efficacy of five brands of ofloxacin tablets available in the Indian market. The physicochemical parameters and assay of the five 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. Weight variation of the tablets proved statistically that all of the tablets were in accordance to the required limits that is not more then 5% deviations. Dissolution test was carried out; none had potency less than 85% within 60minutes the required specification, not less than Q+5%. Pharmaceutical assay was carried out none had potency less than the required specification (90.00% - 100.00%). The dissolution rate and disintegration time were determined in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) without enzymes. All brands complied with the official specification for uniformity of weight, friability, and disintegration and dissolution in both Simulated gastric fluid and simulated intestinal fluid.