Method Development and Validation of Cefixime and Paracetamol in Pharmaceutical Dosage Form by Using RP-HPLC

The Developed RP- HPLC method allows rapid and precise determinations of Cefixime  and Paracetamol. The scope of the present work is to expand and optimization of the chromatographic conditions and to develop RP-HPLC method. A series of mobile phases and columns were tried, among the various mobile phases, Buffer: Acetonitrile (65:35A) (PH-3.5) as an ideal mobile phase, since it gave a good resolution and peak shapes with perfect optimization. The flow rate was optimized at 1 ml/min. The Linearity and correlation coefficient of Cefixime and Paracetamol was found to be 0.999, and 0.999 respectively. Precision was performed and % RSD for Cefixime and Paracetamol were found to be 1.17% and 1.32% respectively. Three concentrations 50%, 100%, 150%, were injected in a triplicate manner and amount recovered and % Recovery was found to be 100%. Limit of detection was calculated by standard deviation method Cefixime and Paracetamol and LOD for Cefixime and Paracetamol were found to be 0.03and 0.02 respectively. Limit of Quantification was calculated by standard deviation method Cefixime and Paracetamol and LOQ for Cefixime and Paracetamol were found to be 0.08 and 0.06 respectively. Small deliberate changes in method like flow rate, mobile phase ratio, and temperature are made but there were no recognized change in the result and are within range as per ICH Guide lines. The average % Assay was calculated and found to be 100.46% and 99.84% for Cefixime and Paracetamol respectively. Hence, the chromatographic method developed for Cefixime and paracetamol is said to be rapid, simple, specific, sensitive, precise, accurate and reliable that can be effectively applied for routine analysis in research institutions, quality control department in Industries, approved testing laboratories, Bio-pharmaceutics and Bio-equivalence studies and in clinical pharmacokinetic studies.