Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Ofloxacin and Cefixime in their Combined Dosage Form

Abstract

The objective of the current study was to develop and validate a simple, accurate, precise and selective stability-indicating gradient reverse phase high performance liquid chromatographic method for simultaneous estimation of Ofloxacin and Cefixime in pharmaceutical formulation in presence of degradation products. The chromatographic separation of Ofloxacin and Cefixime was achieved on Shimadzu LC-20AT series HPLC having C18-ODS bonded column (250 ×4.6 mm, 40 °C, 10 μL) using UV/Visible detector at 276 nm. The optimized mobile phase was consisted of a methanol: phosphate buffer (50:50) at a flow rate of 1.0 ml/m. The retention times were 4.799 and 1.602 m for Ofloxacin and Cefixime respectively. The proposed method provided linear responses within the concentration ranges 5-25 µg/ml for Ofloxacin and Cefixime both. The limit of detection (LOD) and limit of quantification (LOQ) values were found to be 0.0259, 0.078 µg/ml and 0.0206, 0.062 µg/ml for Ofloxacin and Cefixime F respectively. The developed method was validated as per ICH guidelines with respect to specificity, linearity, accuracy, precision, robustness and ruggedness. The studies data revealed that developed method was convenient, fairly reliable, sensitive, less expensive and reproducible.