Development of a Method of Analysis of Ofloxacin in the Complex Preparation "Ofloxazol"

Abstract

Introduction. The creation of new effective antibacterial drugs for the treatment and prevention of purulent-inflammatory diseases is an urgent task of modern pharmacy. Active use in the treatment of purulent infection is found by chemotherapeutic agents from the class of fluoroquinolones, which include ofloxacin.Aim. Development of a method for the quantitative determination of ofloxacin in the complex preparation "Ofloxazol".Materials and methods. For the analysis, the substance ofloxacin, titanium-containing gel "Tizol", solutions of ofloxacin on 95 % ethanol, hydrochloric acid 0.01 mol/l, ointment under the conditional name "Ofloxazol" containing 0.5 % of the drug in the gel "Tizol" were used. The study was carried out by near-UV spectrophotometry.Results and discussion. When studying the absorption spectra, it was found that for the quantitative spectrophotometric analysis of ofloxacin, it is rational to use the wavelength range of 275-320 nm (λmax = 294 nm). Statistical processing of the analysis results showed that the relative error of quantitative determination does not exceed ±1.66 %. The sensitivity of the determination of ofloxacin is 0.245 mcg/ml at A(min) = 0.02. The developed method is validated. Its specificity, linearity, correctness and precision are confirmed. According to the calibration schedule, the content of ofloxacin in the soft dosage form is determined, it is in the range of 0.0483-0.0562 g, which corresponds to the permissible deviations.Conclusion. The conducted studies allowed us to develop and propose a method for the quantitative determination of ofloxacin in the ointment "Ofloxazol", obtained on a titanium-containing basis. The method allows you to evaluate the quality of manufacturing the dosage form, including setting the content of the drug with an error that does not exceed the standard deviations.