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首页> 美国卫生研究院文献>Molecules >Enantioselective Separation of Mirtazapine and Its Metabolites by Capillary Electrophoresis with Acetonitrile Field-Amplified Sample Stacking and Its Application
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Enantioselective Separation of Mirtazapine and Its Metabolites by Capillary Electrophoresis with Acetonitrile Field-Amplified Sample Stacking and Its Application

机译：乙腈场放大样品的毛细管电泳对米氮平及其代谢物进行对映选择性分离及其应用

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摘要

A simple, rapid and sensitive chiral capillary zone electrophoresis coupled with acetonitrile-field-amplified sample stacking method was developed that allows the simultaneous enantioselective separation of the mirtazapine, N-demethylmirtazapine, 8-hydroxymirtazapine and mirtazapine-N-oxide. The separation was achieved on an uncoated 40.2 cm × 75 μM fused silica capillary with an applied voltage of 16 kV. The electrophoretic analyses were carried out in 6.25 mM borate–25 mM phosphate solution at pH 2.8 containing 5.5 mg/mL carboxymethyl-β-cyclodextrin. The detection wavelength was 200 nm. Under these optimized conditions, satisfactory chiral separations of four pair enantiomers were achieved in less than 7 min in vitro. After one step clean-up liquid-liquid extraction using 96-well format, sample was introduced capillary zone electrophoresis with acetonitrile-field-amplified sample stacking to enhance the sensitivity of enantiomers. The method was validated with respect to specificity, linearity, lower limit of quantitation, accuracy, precision, extraction recovery and stability. The lower limit of quantification was 0.5 ng/mL with linear response over the 0.5–50 ng/mL concentration range for each mirtazapine, N-demethylmirtazapine and 8-hydroxymirtazapine enantiomer. The developed and validated method has been successfully applied to the enantioselective pharmacokinetic studies in 12 healthy volunteers after oral administration of rac- mirtazapine.
机译：开发了一种简单，快速，灵敏的手性毛细管区带电泳，并结合乙腈场放大的样品堆叠方法，该方法可同时对映选择米塔氮平，N-去甲基米氮平，8-羟基米氮平和米氮平-N-氧化物。分离是在未涂覆的40.2 cm×75μM熔融石英毛细管上施加的电压为16 kV。电泳分析是在pH值为2.8的6.25 mM硼酸盐–25 mM磷酸盐溶液中进行的，该溶液中含有5.5 mg / mL羧甲基-β-环糊精。检测波长为200nm。在这些优化的条件下，在不到7分钟的时间内即可实现四对对映体的令人满意的手性分离。在使用96孔格式净化液-液的第一步之后，将样品引入毛细管区带电泳，并用乙腈场放大样品堆叠，以提高对映体的灵敏度。该方法在特异性，线性，定量下限，准确性，精密度，提取回收率和稳定性方面得到了验证。每种米氮平，N-去甲基米氮平和8-羟基米氮平对映体的定量下限为0.5 ng / mL，线性响应在0.5-50 ng / mL的浓度范围内。经过开发和验证的方法已成功应用于口服mirmirzazapine的12名健康志愿者的对映选择性药代动力学研究。

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