Evaluation of Quality and Antibacterial Activity of Four Brands of Ciprofloxacin Tablets Marketed in Libya

Abstract

Ciprofloxacin is one of fluoroquinolones antibiotics used in treatment for infections of the urinary tract, skin and soft-tissues, and lower respiratory tract. There are many brands of ciprofloxacin tablets available in pharmacies of Albaiyda city and the aim of this study was to evaluate quality of four available brands of ciprofloxacin tablets by quality control parameters and to test their antibacterial activity. Four leading brands of ciprofloxacin tablet each with a label claim 500 mg were purchased from the various retail pharmacies of Albaiyda city and evaluated by in vitro quality control tests for tablet according to pharmacopeia (BP/ USP) that include evaluation of uniformity of weight and weight variation, friability, hardness, and disintegration time. The second evaluation was the antibacterial activity of the four brands against Klebsiella pneumonia, Staphylococcus aureus, and Escherichia coli by well diffusion susceptibility method. Weight variation for four brands of ciprofloxacin ranged from 0.507% to ,0.753%, the highest variation was found in Brand A, and the lowest weight variation was observed in Brand B and all brands comply with specification. Friability of all brands was below 1% which means that all brands have passed the test and met the specification, and the brand which most likely to be friable between brands is Brand B (0.64%) and the least likely to be friable is Brand C (0 %). The results indicated that all brands of ciprofloxacin tablets were not in the limit of hardness test and the highest hardness value was for Brand C (276 N), and the lowest hardness value was for Brand A (114.2 N). Disintegration time for four brands was under 5 minutes and all brands were complied with the both BP and USP specifications. larger zone of inhibition (ZI) for ciprofloxacin brands against Klebsiella pneumonia was found in Brand C (26.19mm) indicating that it has the highest activity and larger ZI for ciprofloxacin brands against Staphylococcus aureus was found in Brand D (40.40mm) and larger ZI for ciprofloxacin brands against Escherichia coli was also found in Brand D (21.21mm) indicating that it has the highest activity against both types of bacteria. From this study it was demonstrated that all four brands of ciprofloxacin tablet marketed in Libya comply with BP and USP specification for quality control test of uniformity of weight and weight variation, friability, and disintegration time, except that in hardness test in the four brands were found out the limit but this test is non compendial test and all the brands have similar antibacterial effect except Brand C which has slightly better microbiological activity against Klebsiella pneumonia and Brand D which is more effective against Staphylococcus aureus, and Escherichia coli.