手性固定相HPLC法分离测定匹多莫德对映异构体

Enantiomeric separation of pidotimod by HPLC using chiral stationary phase

摘要: 建立匹多莫德光学异构体检查的手性固定相HPLC法，为本品的质量控制提供有效的分析方法。色谱条件为CHIRALPAK^?IA柱(250 mm×4.6 mm,5 μm)，流动相为甲基叔丁基醚-乙腈-三氟乙酸（35∶65∶0.2），柱温25 ℃，流速为1.0 mL/min，检测波长为210 nm。在建立的色谱条件下，匹多莫德与其对映异构体可完全分离。本方法可用于匹多莫德原料中对映异构体的检测。

Abstract: An HPLC method for the determination of the pidotimod enantiomers using amylose tris（3,5-dimethylphenylcarbamate) as chiral stationary phase was developed to control the quality of bulk drug.The separation of pidotimod and its enantiomers were performed on a CHIRALPAK^?IA(250 mm×4.6 mm,5 μm)column at the temperature of 25 °C.The mobile phase consisted of methyl tert-butyl ether-acetonitrile-trifluoroacetic acid(35∶65∶0.2);the flow rate of the mobile phase was 1.0 mL/min and the detection wavelength was 210 nm.Under the established conditions,pidotimod and its enantiomers could be separated completely.This method could be used for the determination of the pidotimod enantiomers.