用手性高效液相色谱法拆分并测定氯苄哌醚联苯酰苯甲酸盐(英文)

氯苄哌醚联苯酰苯酸盐主要用于止咳,L-氯苄哌醚联苯酰苯酸盐具有更高活性.采用手性色谱柱,建立了氯苄哌醚联苯酰苯酸盐光学异构体的拆分方法,并将其用于氯苄哌醚联苯酰苯酸盐的检测.结果表明,采用Chiralcel OD-H柱,在流动相V(正己烷)∶V(异丙醇)∶V(二乙胺)=98∶2∶0.1的条件下,2个异构体能同时达到基线分离,检测波长为254nm,氯苄哌醚联苯酰苯酸盐检测极限为10ng.这表明所建立的分离分析方法可方便可靠地用于该化合物的光学纯度检测.

Separation and determination of D,L-cloperastine fendizoate enantiomer by chiral high-performance liquid chromatography

1- { 2- [ （p-chloro-a-phenylbenzyl） oxy] ethyl } piperidine fendizoate （cloperastine fendizoate）, is an antitussive active pharmaceutical ingredient, and L-cloperastine fendizoate possesses better activi- ty. A high-performance liquid chromatographic （HPLC） method was established for the separation and determination of enantiomers of cloperastine fendizoate. It was found that the two enantiomers of cloperastine fendizoate can be well separated and determined at the detection wavelength of 254 nm with Chiralcel OD-H column comprising a mobile phase of hexane/isopropyl alcohol/diethylamine with a volume ratio of 98 ：2 ： 0.1）. The detection limit of the enantiomer of cloperastine fendizoate is 10 ng, which indicates that the established HPLC method can be well adopted to determine the spectro- metric purity of eloperastine fendizoate.