COMPARATIVE IN VITRO DISSOLUTION STUDY OF SOME CIPROFLOXACIN GENERIC TABLETS UNDER BIOWAIVER CONDITIONS BY RP-HPLC

This study is aimed to assess the bioequivalence of five generic ciprofloxacin tablets from different manufacturer using in vitro dissolution study under biowaiver conditions by RP-HPLC. Dissolution media were USP buffer solutions at pH 1.2 (hydrochloric acid solution), pH 4.5 (acetate buffer solution), and pH 6.8 (phosphate buffer solution). Other general quality assessment tests of these tablets like weight variation, hardness, friability, disintegration time and assay were also determined according to established methods. All brands complied with the official specification for uniformity of weight, friability and disintegration time. Assay of selected tablets revealed that all samples contained over 99% (w/w) of labeled chemical content. The dissolution profiles showed no significant inter brand and intra brand variability. Dissolution results of all the tablet formulations and the innovator brand were further analyzed with difference factor (f1), similarity factor (f2), dissolution efficiency and dunnet,s test. These results indicated that all generic ciprofloxacin tablets included in this investigation were bioequivalent with the chosen innovator brand and so may be used interchangeably.