Validation of a Spectrophotometric Method for Ciprofloxacin 0.2 %, Otic formulation

Abstract

Introduction: Ciprofloxacin 0.2 % in otic drops constitutes the treatment of choice for outer otitis, but it is not available in the country. As an alternative therapy, ophthalmic solutions are used, which are not always adequate from the physiological and therapeutic point of view.

Objective: To validate a spectrophotometric method for quality control of ciprofloxacin 0.2% otic drop.

Methods: The parameters evaluated corresponded to those established internationally for quantitative techniques. Specificity was evaluated against excipients; linearity in the concentration ranged between 80 and 120 %; accuracy at five concentration levels and precision through repeatability and intermediate precision. In the spectrophotometric method, the absorbances of the reference solution and the sample were determined at 277 nm, using distilled water as solvent. The validated method was applied for the titration of pilot batches of the recently elaborated otic drop formula.

Results: It was demonstrated that the method was quite linear, specific, precise and accurate for the determination of ciprofloxacin content in the otic drop formulation. The titration of the pilot batches, freshly produced, met the established criteria. A simple, reproducible and cost-effective method was validated for quality control of the finished product.

Conclusions: The quantification of ciprofloxacin hydrochloride, through the spectrophotometric method, was specific, linear, precise and accurate, thus demonstrating its application for the quality control of the otic formula.