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建立了一种控制优降糖及其复方制剂质量的新方法。以甲氧苄氨嘧啶为内标 ,采用胶束电动毛细管色谱法分离测定了新药消糖灵中的优降糖。电泳条件 :以 2 5mmol/L硼砂 30mmol/L十二烷基硫酸钠 (pH 9 0 )为电泳介质 ,未涂层石英毛细管 (50 μmi.d .× 39 5cm ,有效分离长度 34 8cm)为分离通道 ,压力进样 (68 95kPa·s) ,1 7kV恒压电泳 (2 8℃ ) ,检测波长 2 2 8nm。优降糖在 1 4min内与其他成分得到很好分离 ,且质量浓度为 2 5mg/L~ 2 75mg/L时 ,优降糖可进行定量分析 ,加标回收率为 (1 0 0 6± 1 4 ) %。方法简便、快速 ,结果准确 ,重现性好 ,可用于优降糖复方制剂的质量控制。
A new method of controlling the quality of glyburide and its compound was established. To trimethoprim as the internal standard, using micellar electrokinetic capillary chromatography separation and determination of the new drug Xiaoshuling in glyburide. Electrophoresis conditions: 25mmol / L borax 30mmol / L sodium dodecyl sulfate (pH 90) as the electrophoresis medium, uncoated quartz capillary (50μmi.d × 395cm, effective separation length 34 8cm) for the separation Channel, pressure injection (68 95kPa · s), 1 7kV constant voltage electrophoresis (28 ℃), detection wavelength of 228nm. When the concentration of glibenclamide was well separated from other components in 14min, and the concentration of glibenclamide was 25mg / L ~ 275mg / L, the glibenclamide could be quantitatively analyzed with the recoveries of (1006 ± 1 4)%. The method is simple, rapid, accurate and reproducible, and can be used for quality control of Compound Compound Preparations.