摘要
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 develop a capillary electrophoresis method for determing the enantiomer of ceftriaxone Na.METHODS:A chiral resolving agent,β-cyclodextrin,was employed as chiral additive for ceftriaxone Na enantiomeric separation by capillary electrophoresis.In different electrophoresis polarity mode,the effect of pH of background electrolyte and the concentration of β-cyclodextrin were investigated.RESULTS:The optimal conditions for enantiomeric separation were as follows:separation voltage:28kV,buffer solution:NaH2 PO4 50mmol/L,β-CD 0.04mmol/L,Tirs 3.0mmol/L,pH7.15.CONC_LUSION:The method is simple,sensitive,rapid and accurate,and can be used for the quality control of ceftriaxone Na enantiomers.There was significant difference in contents of enantiomers of ceftriaxone Na between products of two factories.We suggest that a quality control method for ceftriaxone Na enantiomer should be established,which will provide scientific basis for quality control of drug and clinical choice of effective antibioties.
出处
《中国药房》
CAS
CSCD
2002年第1期43-44,共2页
China Pharmacy
基金
全军"十五"医药科研资助项目 (01Q013)
