DEVELOPMENT AND VALIDATION OF A RAPID STABILITY INDICATING CHROMATOGRAPHIC DETERMINATION OF CEFDINIR IN BULK POWDER AND DOSAGE FORM USING MONOLITHIC STATIONARY PHASE

A simple, rapid, and accurate, routine-HPLC method is described for quantitation of Cefdinir in bulk powder and dosage form. The chromatographic separation was carried out on Chromolith Performance RP-18e column, a relatively new packing material consisting of monolithic rods of highly porous silica, using isocratic binary mobile phase of MeOH and 25mM KH2PO4 pH 3.0 in the ratio of 10: 90 at flow rate of 5 mL/min and 40 degrees C. A diode array detector was used at 214 nm for detection. The elution time of Cefdinir was found to be 2.183 +/- 0.003 minutes. The method was validated for system suitability, linearity, precision, limits of detection and quantitation, specificity, stability, and robustness. The robustness study was done for small changes in KH2PO4 concentration and pH, temperature, flow rate, wavelength of detection, % of MeOH in mobile phase, and injection volume. Stability tests were done through exposure of the analyte solution for four different stress conditions: Reflux with 1N HCl, reflux with 1N NaOH, reflux with 30% H2O2 and exposure to UV radiation. The limits of detection and quantification were 0.313 and 0.625 mu gmL(-1), respectively. The recovery value of this method was 98.00% and the reproducibility was within 2.98.