盐酸左旋咪唑片的右旋体监测

分别采用手性高效液相色谱法和旋光法检查和控制盐酸左旋咪唑片中右旋异构体的含量.方法一:使用Chiral AGP手性柱,10 mmol·L-1甲酸铵溶液(pH值约6.2)为流动相,检测波长为214 nm,盐酸左旋咪唑与对映体的分离度大于1.5.方法二:使用二氯甲烷提取后测定旋光度,可有效消除辅料的干扰.两种方法均可用于盐酸左旋咪唑片中的右旋体杂质的控制.

Detection of Dextroisomer in Levamisole Hydrochloride Tablets

The enantiomers of levamisole hydrochloride was detected and controlled by HPLC and polarimetry.In the HPLC method,a chiral AGP column was applied with the mobile phase consisting of 10 mmol·L-1 ammonium formate solution(pH 6.2).Detection wavelength was at 214 nm.The resolution of enantiomers was more than 1.5.In the polarimetry method,extracting with dichloromethane before determination could avoid the disturbance of excipients.Both of the methods can be used for the control of dextroisomer in levamisole hydrochloride tablets.