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,5μm),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。
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.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
2011年第3期238-241,共4页
Journal of China Pharmaceutical University
基金
国家基础科学人才培养基金(国家级大学生实践创新训练计划项目)资助项目(No.J0630858)~~
