David A. Hahn

Aqueous high-performance size-exclusion chromatographic assay for high-molecular-weight impurities in ceftiofur sodium

Abstract An aqueous high-performance size-exclusion chromatographic assay for high-molecular-weight (HMW) impurities in ceftiofur sodium bulk drug is described. The assay uses a sodium dodecyl sulfate micellar mobile phase to provide complete recovery of the analyte from a glycerylpropyl-bonded silica column. Using 254-nm absorbance detection corrected for relative detector response, the assay provides a linear response and complete recovery of HMW impurities. The relative standard deviation for repeated assay of a single bulk drug lot is 2.5%, with systematic variation of column, mobile phase batch, analyst, laboratory, instrument and day. The detection limit is 0.03%.