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目的 :建立一种用高效毛细管电泳法测定酒石酸托特罗定中左旋体含量的方法。方法 :研究了影响对映体拆分的手性选择剂种类和浓度 ,缓冲溶液的组成、浓度和pH ,电泳工作电压 ,温度和检测波长 ,择优选择手性分离的最佳电泳条件 ,用含 2 0mmol·L-1羟丙基 - β -环糊精的 0 1mol·L-1三羟基甲氨基甲烷溶液 (用磷酸调节至 pH =3 0 )作为电泳缓冲液 ,工作电压 2 0kV ,柱盒温度为 15℃ ,检测波长 2 0 4nm ,气压进样 3s。结果 :使右旋 -左旋酒石酸托特罗定对映体基线分离。浓度在 0 0 0 1~ 1 5mg·L-1范围内 ,与峰面积的响应呈良好的线性 ,迁移时间和峰面积的RSD小于 5 % ,左旋体加样回收率为 10 2 1% (n =6 ) ,最低检出浓度为 0 5 μg·mL-1。结论 :本法适用于实验室中酒石酸托特罗定左旋对映体杂质的常规测定
Objective: To establish a high performance capillary electrophoresis method for the determination of tartrate tartrate mid-lutein content. Methods: The optimum electrophoresis conditions for the chiral separation of chiral selectors, the type and concentration of chiral selectors, the composition, concentration and pH of buffer solution, working voltage, temperature and detection wavelength were studied. A 0 1 mol·L-1 trihydroxymethylaminomethane solution (adjusted to pH = 30 with phosphoric acid) of 2 0 mmol·L-1 hydroxypropyl-β-cyclodextrin was used as electrophoresis buffer at a working voltage of 20 kV. The temperature was 15 ℃, detection wavelength 204nm, pressure injection 3s. Results: The dextro-levo-tartrate tartrate antagonist was baseline-separated. The linear range of the peak area was 0 0 0 1 ~ 1 5 mg · L -1, the RSD of migration time and peak area was less than 5%, and the recovery of levofloxacin was 10 2 1% (n = 6), the lowest detection concentration of 0 5 μg · mL-1. Conclusion: This method is suitable for routine determination of L-enantiomer impurities of tolterodine tartrate in laboratory