Development and validation of stability indicating method for simultaneous estimation of ofloxacin and prednisolone in pharmaceutical dosage form

Abstract

Objective: A simple, specific, and fast stability indicating reverse phase liquid chromatographic method was established for simultaneous determination of ofloxacin and prednisolone in pharmaceutical formulations. The High Performance Liquid Chromatography method has adequate separation of Ofloxacin and Prednisolone in its dosage form. Methods: The separation was achieved by BDS Hypersil C 18 , with mobile phase Phosphate Buffer (potassium dihydrogen posphate) (pH 4): Methanol (30:70 v/v).The mobile phase at a flow rate of 1.0 ml/min. Injection volume 20 μl and wavelength of detection used was 275 nm. The retention time for Ofloxacin and Prdnisolone were obtained as 3.327 min and 5.680 min, respectively. Results: The linearity of proposed method was investigated in range of 3-9 μg/ml and 10-30 μg/ml for Ofloxacin and Prednisolone respectively. The precision data for Ofloxacin and Prednisolone were found to be 0.42% and 0.90% respectively. The accuracy of the present method was evaluated at 80%, 100% and 120%. The Accuracy data for Ofloxacin and Prednisolone were found to be 1.12-0.49% RSD and 0.67-0.53% RSD respectively. LOD value was found to be 0.014 for Ofloxacin and 0.0297 for Prednisolone. LOQ value was found to be 0.042 for Ofloxacin and 0.090 for Prednisolone. Conclusions: The method was found to be accurate, precise, specific, sensitive and robust according to acceptance criteria of International Council on Harmonization (ICH) guidelines. The method was resulted in good separation of both the analytes and degradation products with acceptable tailing and resolution. The peak purity index for both the analytes after all types of stress conditions was ≥0.9999 indicated a complete separation of both the analyte peaks from degradation products. The developed method can be applied successfully for simultaneous determination of ofloxacin and prednisolone in pharmaceutical formulations and their stability studies.