Heart-cut 2D-LC/MS approach for pharmaceutical impurity identification using an Agilent 6540 Q-TOF LC/MS System

This Application Note describes a heart-cut two-dimensional LC/MS method for
the identifi cation of a close eluting impurity observed in Duloxetine drug substance
using a non-MS compatible reverse phase LC method. The analysis was performed
using an Agilent 1260 Infi nity LC system coupled with anAgilent 6540 UHD Q-TOF
LC/MS system. Agilent ZORBAX Eclipse Plus columns were used for the fi rst and
second dimensional separation. In the fi rst LC dimension, a non-MS compatible
liquid chromatography (LC) method was performed. Using a column switching
valve, the specifi c unknown impurity was diverted to the second LC column, and
was separated using an MS compatible mobile phase from Pump 2. Accurate mass
MS and MS/MS data of the impurity were acquired using a 6540 UHD Q-TOF. Data
processing using Agilent MassHunter and Agilent Molecular Structure Correlator
(MSC) software enabled quick identifi cation of the unknown impurity. Effi cient and
unambiguous impurity profi ling is possible with minimum user intervention when
using this method.

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