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目的建立更为优化的测定注射用头孢哌酮(CPZ)/舒巴坦(SBT)含量的方法,并测定不同厂家产品含量。方法Nova-PakC18柱(3.9 mm×150 mm,4μm);流动相:0.005 mol.L-1四丁基氢氧化铵水溶液-乙腈(80∶20);流速:1.0 mL.m in-1;检测波长:220 nm。结果CPZ与SBT在各自线性范围内线性关系良好(rCPZ=0.999 8,rSBT=0.999 4,n=6),含量测定结果差异有显著性。结论该方专属性强、简单快捷、准确,可用于该药的含量测定及质量分析,各厂家产品质量存在差异。
Objective To establish a more optimized method for the determination of the content of cefoperazone (CPZ) / sulbactam (SBT) for injection and to determine the content of different manufacturers’ products. Method Nova-Pak C18 column (3.9 mm × 150 mm, 4 μm); mobile phase: 0.005 mol·L-1 tetrabutylammonium hydroxide aqueous-acetonitrile (80:20); flow rate: 1.0 mL.m in-1; 220 nm. Results The linear relationship between CPZ and SBT was linear (rCPZ = 0.999 8, rSBT = 0.999 4, n = 6), and the difference was significant. Conclusion The prescription is strong, simple, quick and accurate. It can be used for the content determination and quality analysis of the drug. There are differences in product quality among different manufacturers.