A comparative study of the dissolution of ciprofloxacin 500 mg tablets

Abstract

Background: Mongolia imports about 70% of its drugs, and about 30% are antibacterial. Of the 42 items of ciprofloxacin registered in Mongolia, 24 tablets, two capsules, nine injection liquids, five eye and ear drops, and two injection powders are registered. Aim: To compare the dissolution of ciprofloxacin 500 mg tablets in the market. Materials and Methods: One series of single-ingredient ciprofloxacin tablets from two domestic and four imported manufacturers, totaling six, were purchased from the market in December 2022 and analyzed according to the Mongolian and British pharmacopeias. Results: The average weight of ciprofloxacin tablets from six manufacturers was 0.768±0.009, 0.735±0.004, 0.784±0.009, 0.799±0.007, 0.577±0.015, and 0.660±0.007 g; drug disintegration in distilled water 1.49±0.026, 10.43±0.305, 1.47±0.064, 3.26±0.169, 11.736±0.555, 3.67±0.44 minutes, in 0.1 N hydrochloric acid 5.42±0.35, 7.16±0.27, 3.54±0.32, and 3.58±0.46 minutes. The content of active substances in one tablet was 0.509±0.004, 0.508±0.002, 0.493±0.002, 0.491±0.004, 0.505±0.002, 0.466±0.002 g. The amount of dissolved substances in 30 minutes was 81.45±14.76%, 95.6±3.23%, 71.44±21.16%, 87.24±23.12%, 77.01±4.02%, and 84.91±7.38%. Compared with the dissolution curve of other samples, the dissolution curve of drug C-6 is similar to that of drug C-2, which has the best solubility. Conclusions: Surveyed Ciprofloxacin of 500 mg tablets of the six manufacturers met the pharmacopeia requirements regarding appearance, average weight, disintegration, and the content of active substances in one tablet, and one manufacturer’s tablets did not meet the requirements in terms of weight variation. The dissolution of Ciprofloxacin 500 mg tablets from four manufacturers was found to meet the pharmacopeia requirements, and the dissolution curves of the two manufacturers were similar.