The invention relates to a method for separating and measuring
levocetirizine dihydrochloride and 5 related substances by using
high performance liquid chromatography. According to the method, a
chromatographic column is a C18
chromatographic column, detection is performed after the
elution of a mobile phase containing a
mixed solution of
sodium heptanesulfonate and
acetonitrile, and alkali is added to the mobile phase. By adopting the method, separation and detection can be simultaneously performed any one or more of 5 related substances in a
levocetirizine dihydrochloride tablet, that is,
levocetirizine dihydrochloride, levocetirizine
lactose ester thereof, levocetirizine
polyethylene glycol ester, p-chlorobenzophenone, p-chlorobenzyl
alcohol and p-chlorodiphenylmethylpiperazine. Compared with the prior art, the degree of separation of the levoctirizine
hydrochloride and the related substances is good, the sensitivity is high and the separation and detection efficiency is improved.