VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CEFIXIME AND MOXIFLOXACIN IN COMBINED PHARMACEUTICAL DOSAGE FORM

Objective: To develop a simple, selective and rapid reversed phase high performance liquid chromatographic (HPLC) method for the analysis of cefixime and moxifloxacin in combined pharmaceutical dosage form as per ICH guidelines. Methods: The separation was achieved from C 18 column at 35 0 C with a mobile phase consisting of methanol: 0.05M heptane sulfonic acid sodium salt,0.5 ml THF and 0.5 ml TEA [75: 25 v/v]. pH-3.8 was adjusted with ortho phosphoric acid at a flow rate of 0.4 ml/min and the retention time was about 6.08 minutes for cefixime and 6.94 minutes for moxifloxacin. The method was selective to cefixime and moxifloxacin able to resolve the drug peak from formulation excipients. Results: The calibration curve was linear over the concentration range of 20-120 μg/ml (r 2 = 0.999) for both drugs. The proposed method was found to be accurate and precise and linear within the desired range. The limit of detection (LOD) and limit of quantitation (LOQ)were calculated statically. Recoveries do not differ significantly from 100% which show there was no interference from the common excipient used in tablet formulation indicating accuracy and reliability of the method. The method was validated as per ICH guidelines and found to be accurate, precise and rugged. The method was validated in terms of linearity, accuracy, precision, specificity, LOD and LOQ. Conclusion: A novel, simple, selective and rapid reversed phase high performance liquid chromatographic (HPLC) method was developed for the analysis of cefixime and moxifloxacin in tablets. Hence,the method can be used for the routine analysis in various pharmaceutical industries.