Original Articles: 2011 Vol: 3 Issue: 3
Quality Control and In Vitro Bioequivalence Studies on Four Brands of Ciprofloxacin Tablets Commonly Sold In Uyo Metropolis, Nigeria
The quality control and in vitro bioequivalence of four brands of ciprofloxacin hydrochloride tablets commonly sold in Uyo, Nigeria, were assessed through the evaluation of the uniformity of weight, friability test, hardness, disintegration test, dissolution rate, and non-aqueous titration procedure with the use of crystal violet solution as indicator. All the brands complied with the official specification for uniformity of weight, hardness and disintegration time. However, for the friability test, one of the four brands (Cefroden), failed to meet the USP specification of maximum friability value of 1%. The dissolution rate profile revealed that one of the four brands (i.e. Cefroden) did not attain up to 70% dissolution throughout the period of the determination, while the other brands had above 70% release in less than 45min. The non-aqueous titrimetric procedure showed that three brands have values within the range specified for content uniformity in the USP (95-105%), while the remaining one brand (Cefroden) gave a lower value. Three of the four brands evaluated in this study could be regarded as being biopharmaceutically and chemically equivalent, while one brand is obviously a sub-standard product. The nonaqueous 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. The analysis of variance showed that there is significant difference (p< 0.001) in the release profile of the four brands of ciprofloxacin tablets. Cipronol having the highest release profile while Cefroden had the least.