The application discloses a method for determining potential
genotoxic impurities in
levocarnitine by GC-MS, comprising the following steps: preparing a
test sample solution: taking 0.2-3g of
levocarnitine, accurately weighing, placing in a centrifugal tube, adding 1-2ml of water, shaking to dissolve the sample, adding 5ml of
acetone, first shaking to extract, then sealing and centrifuging, and taking the supernatant; preparing a
control sample solution; respectively performing GC-MS detection on the
control sample solution and the
test sample solution, and determining the content of 2,3-dichloro-1-
propanol and 1,3-dichloro-2-
propanol in the
levocarnitine by an external standard method. The application adopts GC-MS to determine the potential
genotoxic impurities 2,3-dichloro-1-
propanol and 1,3-dichloro-2-propanol in levocarnitine, and has high separation efficiency, fast analysis speed and high detection sensitivity, and can effectively control the quality of the levocarnitine.