Comparative evaluation of the biopharmaceutical and chemical equivalence of some commercially available brands of ciprofloxacin hydrochloride tablets

Abstract

Purpose: This study was undertaken with the objective of evaluating the biopharmaceutical equivalency of ten brands of ciprofloxacin tablets and the chemical equivalency with the use of an analytical method, which will be easy to use, accurate, reproducible, simple, and inexpensive. Method: The biopharmaceutical and chemical equivalence of ten brands of ciprofloxacin hydrochloride tablets were assessed through the evaluation of the uniformity of weight, friability test, hardness, disintegration test, dissolution rate, thin layer chromatography and non-aqueous titration procedure with the use of crystal violet solution indicator. Result: All the brands complied with the official specification for uniformity of weight and friability test, while one of the brands failed the disintegration test. The dissolution rate profile revealed that four of the brands did not attain 70% dissolution throughout the period of the determination, while the other brands had above 70% dissolution at less than 45minutes. The non-aqueous titrimetric procedure showed that the excipients did not affect the procedure; with seven brands having values within the range specified in the USP, while the remaining three brands gave lower values. Conclusion: Six of the brands evaluated in this study could be regarded as being biopharmaceutically and chemically equivalent, while a particular brand is obviously a fake product. The non-aqueous titrimetric procedure used in this study is simple, inexpensive, and easy to use and could be used in routine monitoring of the quality of ciprofloxacin HCl tablets, especially in the absence of high technology equipments that are not easily available in most developing countries. (19 refs.)