The present study describes a rapid and effective capillary electrophoresis (CE) method for the enantioseparation of pindolol using single-isomer octa(6-O-sulfo)-γ-cyclodextrin. The complexation parameters were determined under neutral and high pH conditions to identify optimal separation conditions using a theoretical model. Baseline separation of pindolol enantiomers was achieved within 6 min in a sodium/MOPS buffer, pH 7.2, with a selector concentration of 6 mM. The method was validated according to the ICH guidelines using imidazole as an internal standard. Low limits of detection and quantification were found, specifically 1.2 $\mathrm{\mu }\mathrm{g}/\mathrm{m}\mathrm{L}$ and 4 $\mathrm{\mu }\mathrm{g}/\mathrm{m}\mathrm{L}$ (0.6 $\mathrm{\mu }\mathrm{g}/\mathrm{m}\mathrm{L}$ and 2 $\mathrm{\mu }\mathrm{g}/\mathrm{m}\mathrm{L}$ per enantiomer), respectively. The calibration curves showed good linearity, with a coefficient of determination $R^2$ ≥ 0.999 over a 5 – 55 $\mathrm{\mu }\mathrm{g}/\mathrm{m}\mathrm{L}$ concentration range and over a 50 – 300 $\mathrm{\mu }\mathrm{g}/\mathrm{m}\mathrm{L}$ concentration range of the racemic mixture. The relative standard deviations (%RSD) of intra-day and inter-day precision were lower than 8% at LOQ level, lower than 3% at 50 $\mathrm{\mu }\mathrm{g}/\mathrm{m}\mathrm{L}$ level and lower than 1.5% at 300 $\mathrm{\mu }\mathrm{g}/\mathrm{m}\mathrm{L}$ level. Accuracy ranged from 95 to 103% (106% at LOQ level). The proposed method was successfully tested on a medical formulation of Visken® Sandoz intravenous solution and Visken® Teofarma pills for oral use.

本研究描述了一种快速和有效的毛细管电泳（CE）方法，用于使用单一异构体八（6-O-磺基）-γ-环糊精对苯二酚进行对映体分离。在中性和高pH条件下确定络合参数，以使用理论模型确定最佳分离条件。在pH 7.2的钠/ MOPS缓冲液中，选择子浓度为6 mM的情况下，在6分钟内即可实现品多洛尔对映体的基线分离。该方法已根据ICH指南使用咪唑作为内标进行了验证。发现检测和定量的低限，特别是1.2$\mathrm{\mu }\mathrm{G}/\mathrm{米}\mathrm{大号}$ 和4 $\mathrm{\mu }\mathrm{G}/\mathrm{米}\mathrm{大号}$ （0.6 $\mathrm{\mu }\mathrm{G}/\mathrm{米}\mathrm{大号}$ 和2 $\mathrm{\mu }\mathrm{G}/\mathrm{米}\mathrm{大号}$每个对映体）。校准曲线显示出良好的线性，并具有确定系数${\mathrm{[R}}^{\mathrm{2个}}$ ≥0.999（5 – 55） $\mathrm{\mu }\mathrm{G}/\mathrm{米}\mathrm{大号}$ 浓度范围在50 – 300之间 $\mathrm{\mu }\mathrm{G}/\mathrm{米}\mathrm{大号}$外消旋混合物的浓度范围。日内和日间精度的相对标准偏差（％RSD）在LOQ级别下低于8％，在50时低于3％$\mathrm{\mu }\mathrm{G}/\mathrm{米}\mathrm{大号}$ 且低于300时的1.5％ $\mathrm{\mu }\mathrm{G}/\mathrm{米}\mathrm{大号}$等级。准确度范围为95％至103％（LOQ级别为106％）。所提议的方法已在用于口服的Visken®Sandoz静脉内溶液和Visken®Teofarma药丸的药物制剂上成功测试。