CAJ | 학술논문

目的：建立毛细管电泳法检查盐酸左西替利嗪片中右旋异构体杂质。方法：用磺酸化-β-环糊精（ S-β-CD）作为手性选择剂，考察了S-β-CD浓度、pH值和缓冲盐浓度对分离的影响。结果：在30 mmol/L磷酸盐运行缓冲液（含20 g/L S-β-CD，pH 7．0）中，西替利嗪对映体在分离电压为15 kV的条件下得到良好分离，并满足对盐酸左西替利嗪片检查右旋异构体杂质所需要的条件。结论：本实验建立的方法灵敏、可靠，可用于左旋西替利嗪中右旋异构体杂质的检查。
목적：건립모세관전영법검사염산좌서체리진편중우선이구체잡질。방법：용광산화-β-배호정（ S-β-CD）작위수성선택제，고찰료S-β-CD농도、pH치화완충염농도대분리적영향。결과：재30 mmol/L린산염운행완충액（함20 g/L S-β-CD，pH 7．0）중，서체리진대영체재분리전압위15 kV적조건하득도량호분리，병만족대염산좌서체리진편검사우선이구체잡질소수요적조건。결론：본실험건립적방법령민、가고，가용우좌선서체리진중우선이구체잡질적검사。
Objective: To determine enantiomeric impurity in levocetirizine tablets by using capillary electrophoresis .Methods:The effects of pH and the concentrations of sulfated-β-cyclodextrin ( S-β-CD ) and buffer salt on chiral resolution were examined with S-β-CD as chiral selector .Results: A good enantioseparation of cetirizine was achieved with 30 mmol/L NaH2PO4 buffer solution (pH 7.0) containing 20 g/L of S-β-CD.Conclusion: The method developed in the study is sensitive and reliable for determination of enantiomeric impurity in levocetirizine tablets .