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

Abstract

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 25 mM KH₂PO₄ pH 3.0 in the ratio of 10:90 at flow rate of 5 mL/min and 40°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 1 N HCl, reflux with 1 N NaOH, reflux with 30% H₂O₂ and exposure to UV radiation. The limits of detection and quantification were 0.313 and 0.625 µgmL⁻¹, respectively. The recovery value of this method was 98.00% and the reproducibility was within 2.98.

Keywords:

• cefdinir
• monolithic columns
• rapid stability indicating LC-method
• stress degradation

ACKNOWLEDGMENT

This study was financed through Zagazig University, Egypt (Support of Academic Research in Zagazig University Project, fourth stage, 2010).

Notes

*coefficient of variation (%) = S.D. × 100/mean.

**accuracy (%) = observed concentration × 100/used concentration.

^a n = 7.

^b Theoretical values for t and f at P = 0.05.