Development and Validation of RP-HPLC Method for Simultaneous Estimation of Clavulanic acid and Cefpodoxime Proxetil in Combined Pharmaceutical Dosage Form
Journal Title: International Journal of Pharma Research and Health Sciences - Year 2014, Vol 2, Issue 6
Abstract
The objective of present work was to develop and validate a simple, accurate, precise HPLC method for the estimation of clavulanic acid and cefpodoxime proxetil. The chromatographic separation was achieved on a Hypersil BDSC18column (4.6x250 mm, 5ÎĽmparticlesize). Different mobile phase systems in different proportions were tried. For HPLC method a mobile phase consisting of Acetonitrile and Methanol (75:25) produced symmetric peak shape with good resolution for both the drugs. Next, the drugs were chromatographed under different flow rates from which a flow rate of 1.0 ml/min was selected. The retention timesof clavulanic acid and cefpodoxime proxetil were found to be 2.951 min and 4.195 min, respectively.The proposed method was found to have excellent linearity in the concentration range of 20-80mg/ml with correlation coefficient r2=0.999 and 0.999 for clavulanic acid and cefpodoxime proxetil repectively.The method was validated for linearity, precision, LOD, LOQ and robustness.The proposed method optimized and validated as per ICH guidelines.
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