水包油型微乳液相色谱分离激素类药物的影响因素

Influence factors of the separation of steroids using oil-in-water microemulsion liquid chromatography

采用水包油型微乳液相色谱(MELC)分离了6种激素类药物(醋酸可的松、泼尼松龙、己烯雌酚、炔雌醇、醋酸氟轻松及黄体酮)。考察了微乳流动相的组成成分(包括表面活性剂的浓度、油相种类、有机添加剂种类)及固定相孔径等对分离的影响。实验得到的最佳分离条件:色谱柱为Venusil ASB C18(T)(粒径5μm,孔径30nm,250mm×4.6mm),微乳流动相为30g/L十二烷基硫酸钠(SDS)-0.8%正辛烷-6.6%正丁醇,流速为0.8mL/min,检测波长为254nm,柱温为35℃。该方法可用于甾体药物及其制剂的分离鉴别以及快速测定。

The effect of the varying operating parameters on the separation of steroids was studied by oil-in-water microemulsion liquid chromatography （MELC）. The parameters included the surfactant concentration, the type of oil phase, the nature of organic solvent additives, and the pore size of the stationary-phase. The optimized conditions for the separation of 6 steroids were as follows： a Venusil ASB C18（T） column （5 μm, 30 nm, 250 mm×4.6 mm） was used at 35 ℃, the microemulsion mobile phase consisted of 30 g/L sodium dodecylsulfate （SDS）, 0.8%（w/w） n-octane, 6.6%（w/w） n-butanol. The optimized method can be used for the separation, identification and simultaneous determination of steroids in bulk drugs and in pharmaceutical dose forms.