毛细管电泳高频电导法测定复方制剂中醋酸氯己定的含量  

Determination of chlorhexidine acetate in compound preparations by capillary electrophoresis with high frequency conductivity detection

作　　者：李全文[1] 王峻梅[1] 吴小林[2] 周勰[1] 陈缵光[1] 韦莉萍[3] 

机构地区：[1]中山大学药学院,广州510089 [2]中山大学附属第三医院,广州510630 [3]南方医科大学南校区,广州510315

出　　处：《药物分析杂志》2006年第7期975-977,共3页Chinese Journal of Pharmaceutical Analysis

基　　金：广东省自然科学基金重点项目(021808);广东省教育厅科学基金项目(Z03055)

摘　　要：目的:建立毛细管电泳高频电导法分离检测3种复方制剂中醋酸氯己定的分析方法。方法:以融硅毛细管(150μm×60 cm)为分离柱,研究了缓冲液的种类、浓度、添加剂种类与添加量、分离电压和进样量等因素对分离和检测的影响,优化选择0.5 mmol·L^(-1)醋酸+3.0 mmol·L^(-1)醋酸钠缓冲液为电泳介质,分离电压15.0 kV,可实现口炎康漱口液、妇炎洁栓、洁阴抗菌洗液等复方制剂中醋酸氯己定的分离和检测。结果:在优化条件下醋酸氯己定线性范围为10.0～200μg·mL^(-1),线性相关系数为0.998,检出限为5.0μg·mL^(-1)(S/N=3)。3种样品不同浓度添加水平的日内和日间 RSD 均小于5%,加标回收率分别为:口炎康漱口液93.2%～98.7%、妇炎洁栓剂91.2%～93.5%、洁阴抗菌洗液99.8%～103%。结论:该方法简便、快速,灵敏度高,可以用于这些制剂的质量控制。Objective：To establish a method for determination of chlorhexidine acetate in three different compound preparations by capillary electrophoresis with high frequency conductivity detection（ contactless conductivity detection）. Method： The electrophoretic parameters, such as the variety and concentration of buffer solution, separation voltage etc,were researched. Chlorhexidine acetate was separated and detected in acetate buffer（0. 5 mmol · L^-1 HAc ＋ 3.0 mmol · L^-1 NaAc） at 15. 0 kV of constant voltage. Results：The linear concentrations ranged from 10. 0 to 200 μg · mL^-1 （ r = 0. 998 ）, the limit of detection （LOD） reached 5. 0 μg · mL^-1 （ SIN = 3 ）. The RSDs for both intra - day and inter - day were less than 5% and recoveries were 93.2% - 98.7% ,91.2% - 93.5%, and 99.8% - 103% for Kou - yan - kang gargle ,Jie - yin antibacterial lotion and Fu - yan -jie suppository respectively at various spiked levels. Conclusion：This study provided a useful method for the determination of chlorhexidine acetate in compound preparations. It could be used for the quality control of products due to its simplicity, rapidity and sensitivity.

关 键 词：毛细管电泳 高频电导检测 非接触式电导检测 醋酸氯己定 制剂 

分 类 号：R917[医药卫生—药物分析学]