右旋佐匹克隆中手性杂质含量测定的方法学研究Methodology study of the content determination of chiral impurity in the S-zopiclone
王国成,杨芳,杨丽萍,郭立民
WANG Guo-cheng; YANG Fang; YANG Li-ping; GUO Li-min(Chem-Pharm R&D Institute;
摘要(Abstract)：
目的建立右旋佐匹克隆中手性杂质含量的测定方法。方法RP HPLC法 ,色谱柱为CHI RALCELOD R( 2 5 0mm× 4 6mm ,5 μm) ;流动相为乙腈 磷酸氢二钠缓冲液 ( pH =6 5 ,V∶V =5 0∶5 0 ) ;流速 0 6mL·min-1;检测波长为 3 0 5nm ;柱温 3 5℃。结果右旋佐匹克隆质量浓度在 0 5～8 0mg·L-1内 ,线性关系良好 (r=0 9998)。结论可用于右旋佐匹克隆中手性杂质的含量测定。
Objective To develop a reversed-phase HPLC method so as to determine the chiral impurity content in the S-zopiclone.Methods A CHIRALCEL OD-R(250 mm×4.6 mm,5 μm)column was used,the mobile phase was composed of acetonitriledisodium hydrogen phosphate(V∶V=50∶50) and the detect wavelength was 305 nm.Results The linear calibration curves were obtained in the concentration range of 0.5～8 mg·L-1(r=0.999 8).Conclusion This method is convenient,rapid,accurate,economic and suitable for the determination of chiral impurity in the S-zopiclone.
关键词(KeyWords)：
右旋佐匹克隆;手性杂质;含量测定
S-zopiclone; chiral impurity; content determination
基金项目(Foundation):
作者(Authors):
王国成,杨芳,杨丽萍,郭立民
WANG Guo-cheng; YANG Fang; YANG Li-ping; GUO Li-min(Chem-Pharm R&D Institute;
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