This invention relates to a method for detecting
zopiclone impurities, the method comprising the following steps: Step A: preparation of
diluent; Step B: preparation of
test solution: take
zopiclone, add
diluent, and dilute to prepare a
test solution; Step C: preparation of reference solution: take
impurity 6-(5-chloro-2-pyridinyl)-7-ethoxy-5,6-dihydropyrrolo[3,4-b]pyrazin-5-one reference standard and
zopiclone reference standard, add
diluent, sonicate to dissolve, and prepare a reference solution; Step D: determination method: take the
test solution and reference solution respectively, inject them into a high-performance liquid chromatograph,
record the chromatogram, and calculate the
impurity content; wherein, the chromatographic conditions are: using octadecylsilane-bonded
silica gel as the packing material; using
acetonitrile-buffered
saline solution as the mobile phase; flow rate of 0.5 mL to 2.5 mL per minute; detection
wavelength of 280 nm to 320 nm;
column temperature of 25 °C to 35 °C;
sample chamber temperature of 0 °C to 15 °C;
injection volume of 10 to 30 μl.