The invention relates to the field of pharmaceutical analysis, in particular to a method for determining the content of
phenol and m-
cresol in an
insulin preparation based on GC-MS / MS (
Gas Chromatography-
Mass Spectrometry /
Mass Spectrometry). The method comprises the following steps: (1) precisely measuring
human insulin injection or
insulin glargine injection, putting into a measuring flask, diluting by 100 times with a
methanol aqueous solution, uniformly shaking, precisely measuring, putting into the measuring flask, diluting by 10 times with the
methanol aqueous solution, and taking as a
test solution; (2) a
quartz capillary column is adopted, the
column temperature is kept at 200 DEG C for 5 min, the sample size is 1 microliter, the split ratio is 10: 1, and carrier gas is
inert gas; (3) an
ionization source is an
electron bombardment
ion source, the energy is 70 eV, the temperature of the
ion source is 200 DEG C, the interface temperature is 250 DEG C, the
solvent delay is 1 min, the
mass scanning range is 45-500 m / z, the
electron multiplication
voltage is 3.0 kV, the collision gas is
inert gas, and multi-reaction monitoring MRM and full scanning Scan are collected at the same time. The specificity, the
linear range, the accuracy, the
repeatability, the stability and the durability of the method are superior to those of the prior art.