COMPARATIVE IN VITRO BIOEQUIVALENCE ANALYSIS OF SOME CIPROFLOXACIN HCl GENERIC TABLETSAbstract
Six generic ciprofloxacin HCl 250 mg tablets from different manufacturer have been evaluated to assess their bioequivalence using in vitro tests. Other general quality assessments of these tablets like assay, weight variation, hardness, friability, disintegration time were also determined and all these generic tablets passed compendial specifications. There were no significant differences (p < 0.05) in the percentage dissolution of drug from generic tablets at 15 minutes with the same from innovator brand tablet at the same time point. To compare the dissolution profiles of all the tablet formulations and the innovator brand, a model independent approach of difference factor (f1) and similarity factor (f2) was employed with all time points included in the in vitro dissolution studies. These results indicated that all generic ciprofloxacin HCl tablets included in this investigation were bioequivalent with the chosen innovator brand and so may be used interchangeably.
Amit Kumar Nayak and Dilipkumar Pal *
College of Pharmacy, Institute of Foreign Trade & Management 2, Lodhipur Rajput, Delhi Road, Moradabad (UP), India
29 March, 2010
08 June, 2010
03 July, 2010
01 August, 2010