Determination of High Molecular Polymers in Cefoperazone Sodium and Sulbactam Sodium for Injection by Molecular Exclusion Chromatography

OBJECTIVE To establish a method for the determination of high molecular polymers in cefoperazone sodium and sulbactam sodium for injection. METHODS Chromatographic analysis was performed on Sephadex G-10 column(15.0 mm×300 mm), 0.05 mol·L^-1 phosphate buffer (pH 7.0) as the mobile phase A, and super pure water as the mobile phase B. The flow rate was 1.2 mL·min^-1 and the detection wavelength was 254 nm. RESULTS High molecular polymers in cefoperazone was separated completely from cefoperazone. The linear range of cefoperazone was 5.01-250.71 μg·mL^-1(r=0.999 9). The linear range of the substances examined was 10.13-30.24 mg·mL^-1(r=0.999 9). The limit of quantification was 0.14 μg. The RSD for replicate injections of reference solution was 0.50%(n=5), the repetitiveness and the reproducibility were fine, the RSDs were 0.82%(n=5) and 3.4%(n=3), respectively. CONCLUSION The method is simple, rapid and reliable. It is applicable for the quality control of cefoperazone sodium and sulbactam sodium for injection.