ABSTRACT:
Objective: To develop an echo-friendly, simple, and rapid reversed phase high performance liquid chromatographic (RP-HPLC) method for simultaneous determination of ciprofloxacin (CIP) and fluocinolone acetonide (FluA) as a minor component in bulk and in an otic drop. Method: CIP and FluA were separated with a C18 column (EC 250/4.6 NUCLEODUR 100-5 C18 ec) at 40°C oven temperature and flow rate of 1mL/min. The mobile phase consists of 65:35 methanol: phosphate buffer (pH 3). The buffer contains 0.0125M Heptanesulfonic acid as an ion- pair agent. The analytes were measured with a UV-photo diode array detector at 239 nm. Results: Chromatograms of high resolution were obtained and the retention times of CIP and FluA were 3.1 and 6.8 min, respectively, and the runtime is only 9 minutes. The method was linear over the concentrations ranging from (20-250)µg/mL for ciprofloxacin and (2.5-600)µg/mL for fluocinolone acetonide, respectively. The assay percentages of ciprofloxacin and fluocinolone acetonide in raw materials were found to be 101.44% and 101.80%, respectively. The developed method was validated by determining its linearity, accuracy, precision, specificity and system suitability. Conclusion: Developed method showed good reproducibility, and the results were within the accepted limits. It was demonstrated that the method can be successfully applied for the routine determination of CIP and FluA in bulk and pharmaceutical dosage forms.