Development of Stability-Indicating Liquid Chromatographic Method for Analysis of Cefoxitin Sodium in Sterile Formulation.

Abstract

Stability-indicating high performance liquid chromatography (HPLC) method was developed and validated for analysis of cefoxitin sodium in its powder for injection dosage form. Chromatographic separation was achieved on a C18 µBondapack (300×3.9, 10µ) column, maintained at 30°C with a mobile phase consisted of water: acetonitrile: glacial acetic acid (800:190:10) and a flow rate of 0.9mL/min. The peak was detected at 254nm & the retention time was obtained at 16.74 min. The peak area plot was linear over the concentration range of 72.16µg/mL to 451.04µg/mL. The different experimental parameters affecting the drug stability were optimized. The method was validated for accuracy, precision, reproducibility, specificity, robustness and ruggedness in accordance with International Conference on Harmonization (ICH) guidelines. The proposed method was successfully applied for the analysis of cefoxitin sodium in drug substance and drug product in the presence of hydrolytic and oxidative degradants. 

KEYWORDS: Cefoxitin sodium, Degradation, Stress condition, Stability-indicating.