Abstract

PEREZ NAVARRO, Maikel; RODRIGUEZ HERNANDEZ, Yaslenis  and  SUAREZ PEREZ, Yania. Validation of the ultraviolet spectrophotometry method for the quality control of ciprofloxacin chlorhydrate in Ciprecu tablets. Rev Cubana Farm [online]. 2014, vol.48, n.2, pp.199-212. ISSN 0034-7515.

Introduction: quinolones are a group of antimicrobials of high clinical significance. Ciprofloxacin hydrochloride monohydrate is a second-generation antibacterial fluoroquinolone for treatment of several infections and is marketed as eye drops, injections, capsule and tablets. Objective: to develop and to validate an ultraviolet spectrophotometric analytical method to be used in the quality control of ciprofloxacin hydrochloride monohydrate in newly manufactured Ciprecu tablets. Methods: this method was devised at the laboratory and thoroughly validated pursuant to the category I parameters. The method was selected on account of the existence of chromophore groups in the structure of the analyzed compound. The maximum absorption wavelength was set at 273 nm of 5 µg/mL in 0.1 mol/L hydrochloric acid. Results: based on the validation process, it was demonstrated that this method has adequate specificity against the study matrix components, as well as its linearity, accuracy and precision in the range of 2.5 to 7.5 µg/mL. The results of the application of this method were similar to those of the official procedure suggested for the same purposes in USP 33, 2010. Conclusions: The analytical method was valid for the suggested purposes, so it is a new simple, rapid and economic alternative for the quality control of Ciprofloxacin hydrochloride in Ciprecu tablets.

Keywords : ciprofloxacin hydrochloride monohydrate; ultraviolet spectrophotometry; validation; quality control; tablets.

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