硫酸沙丁胺醇的手性分离

Chiral separation of salbutamol sulfate

目的:建立硫酸沙丁胺醇高效液相色谱(HPLC)法和毛细管电泳(HPCE)法的手性拆分方法。方法:采用 Chiral-AGP手性柱(100mm×4.0mm,5μm),以10mmol·L^(-1)的甲酸铵为流动相,进行液相色谱分离。采用区带毛细管电泳法,未涂层石英毛细管(50μm×67cm.有效长度50cm),气压进样(5kPa,6s),柱温为20℃,电压为-20kV,运行缓冲液:含2%磺化-β-环糊精的20mmol·L^(-1)磷酸二氢钠溶液(pH 为3.5)。2种方法的检测波长均为226nm。结果:采用 HPLC 和 HPCE 方法均可以分离硫酸沙丁胺醇的两异构体。两异构体 HPLC 的分离度为1.4,HPCE 的分离度为14。HPCE 的线性范围为5～250μg·mL^(-1),检测限为2μg·mL^(-1)。结论:HPCE 法的分离效果优于 HPLC 法,且毛细管电泳法简便可靠。

Objective：To establish an HPLC and an HPCE method for the separation of two enantiomers of salbutamol sulfate. Methods：The separation of HPLC was performed on a Chiral -AGP column of 100 mm ×4. 0 mm（5 μm）. 10 mmol · L^-1 Ammonium formate was used as mobile phase. The separation of HPCE was performed on a fused silica capillary （50 μm × 67 cm,50 cm effective length）. 2% 13 -Cyclodextrin sulfated sodium salt in 20 mmol · L^- 1 sodium dihydrogen phosphate （ pH 3.5 ） was used as running buffer. Sample was injected hydrodynamically into the capillary. The applied voltage was - 20 kV. The detection was set at 226 nm in both methods. Resuits：The two enantiomers of salbutamol sulfate could be separated by HPLC and HPCE. The resolutions of HPLC and HPCE were 1.4 and 14 respectively. The linearity range of HPCE was 5 -250 μg · mL^-1 ,the detection limit of HPCE was 2 μg· mL^-1 Conclusion： The method of HPCE is better than HPLC for the separation of salbutamol sulfate, and easy and reliable.