【摘要】 建立了毛细管电泳高频电导法测定复方制剂中硝酸咪康唑含量的分析方法。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3.0 mmol/L乳酸+10%乙醇缓冲液为电泳介质,分离电压20.0 kV,可实现分离检测。在优化条件下硝酸咪康唑线性范围为20.0~900 mg/L,线性相关系数为0.999 4,检出限为1.0 mg/L(S/N=3)。2种制剂不同浓度添加水平的日内和日间RSD均小于3%,2种制剂的加标回收率分别为94.9%~101%和95.3%~99.1%。方法简便、快速、灵敏度高,可以用于硝酸咪康唑相关制剂的质量控制。更多还原

【Abstract】 A method for the determination of miconazole nitrate in two different medicines by capillary electrophoresis with high frequency conductivity detection(contactless conductivity detection) was(established).The electrophoretic parameters, such as the variety and concentration of buffer solution,separation voltage etc,were researched.Miconazole nitrate was separated and detected in a buffer(3.0 mmol/L lactic acid+10%ethanol(pH=4.0)) at 20.0 kV constant voltage.The linear dependence of the concentrations of miconazole nitrate ranged from 20.0 to 900 mg/L(r=0.999 4),and the limit of detection(LOD) reached 1.0 mg/L((S/N=)3).The RSDs for both intra-day and inter-day were less than 3% and the recoveries were 94.9%~101% and 95.3%~99.1% for Miconazole-nitrate-cream and Miconazole-nitrate-vaginal-suppositories(suppository)(respectively) at various spiked levels.This method may be useful for the determination of(miconazole) nitrate in compound preparations.It could be used for quality control of products due to its(simplicity),rapidity and sensitivity.更多还原