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目的 :建立测定头孢曲松钠对映体含量的CD毛细管电泳方法。方法 :在不同电极性的条件下 ,运用 β-环糊精 (CD)手性添加剂毛细管电泳方法 ,同时考察了背景电解质pH值及 β-CD浓度对手性拆分的影响。结果 :拆分头孢曲松钠对映体的最佳条件 :缓冲液为50mmol/Lβ-CD ,3 0mmol/L三羟甲基氨基甲烷 ,分离电压为28kV ,pH为7 15。结论 :实验结果表明 ,在优化的实验条件下 ,头孢曲松钠对映体得到了基线分离。用该方法测定不同厂家的头孢曲松钠中两种对映体的含量 ,结果表明 ,不同厂家的头孢曲松钠中对映体的含量明显不同 ,故应建立控制头孢曲松钠对映体质量的方法。该方法可为药品质量控制及临床有效选择抗菌药物提供理论依据。
Objective: To establish a CD capillary electrophoresis method for the determination of enantiomeric content of ceftriaxone sodium. Methods: Capillary electrophoresis with β-cyclodextrin (CD) chiral additive was carried out under different electropositive conditions. The effect of background electrolyte pH and β-CD concentration on chiral resolution was also investigated. Results: The optimum conditions for the separation of ceftriaxone sodium enantiomers were as follows: 50 mmol / L β-CD and 30 mmol / L tris (hydroxymethyl) aminomethane. The separation voltage was 28 kV and the pH was 7 15. Conclusion: The experimental results show that the enantiomers of ceftriaxone are baseline separated under the optimized experimental conditions. The determination of the two enantiomers in ceftriaxone sodium from different manufacturers by this method showed that the contents of enantiomers in ceftriaxone sodium from different manufacturers were significantly different. Therefore, the enantiomers of ceftriaxone sodium Quality method. The method can provide a theoretical basis for quality control of drugs and effective selection of antibacterial drugs clinically.