Determination of residual solvents in cefotetan disodium by headspace gas chromatography / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish a method for determining nine residual solvents in cefotetan disodium by headspace gas chromatography. METHODS: The residual solvents including methanol, acetone, acetonitrile, dichloromethane, butanone, ethyl ace-late, tetrahydrofuran in cefotetan disodium were quantitatively determined on a DB-624 column (30 m×0.32 mm, 1.8 μm). Water was solvent media. The residual solvents of anisole and isocaprylic acid in cefotetan disodium were quantitatively determined on a HP-FFAP column (25 m×0.32 mm, 0.5 μm). The 20% dimethylsulfoxide (DMSO) was used as the solvent. RESULTS: Nine residual solvents were completely separated. Good linearity of the solvents were obtained within the determination ranges. There between 0.9988 and 0.9997. The average recoveries of three levels were in the range of 95.71%-103.55%. The RSDs were 0.39%-2.28%. CONCLUSION: The established two methods are accurate and sensitive, and can be used for the determination of residual solvents in cefotetan disodium.