Validation of the chromatographic method for stability studies of ciprofloxacin hydrochloride 0,2 % otic drop

Abstract

ABSTRACT

Introduction: Ciprofloxacin 0.2% otic drop is a β-lactam antibiotic with a broad antibacterial spectrum.

Objective: Validate a method to evaluate the analytical and stability behavior of the ciprofloxacin hydrochloride 0.2 % otic drop .

Methods: The method was based on the separation of the active substance through an Apollo-C18 chromatographic column (5 μm) (250 x 4.6 mm), with ultraviolet detection at 277 nm. A mobile phase composed of a mixture of 870 mL of solution A (phosphoric acid 0.025 mol/L adjusted with triethylamine at pH 3 ± 0.1) and 130 mL of acetonitrile was used, with a flow rate of 2.0 mL/min. The calibration curve was performed in the range of 2.4 to 3.73 10-4 mol/L, (from 80% to 120% of the amount proposed in the technique).

Results: The method was linear, with a correlation coefficient of 0.9998; the statistical test for interception and slope was non-significant. A recovery of 99.9% was obtained in the range of concentrations studied and the Cochran and Student's t tests were not significant. The coefficient of variation in the repeatability study was 0.26% for the 6 replicates tested. In the intermediate precision analyses, the probability values were greater than 0.05, for a 95.0% confidence. In the specificity study, no interference from additional peaks was observed near the retention time of the main product. The analytical method was linear, precise, specific and accurate in the range of concentrations studied.

Conclusions: The validated analytical method for the quantification of the active ingredient ciprofloxacin hydrochloride 0.2 %, allows that for the first time a safe and effective otic medicine appears in the Basic Table of Medicines of Cuba.