关键词: font-size:medium, ">佐匹克隆；有关物质；校正因子；高效液相色谱法；影响因素

Abstract: Objective： To determine the relative correction factors of the known impurities and catalyst of Zopiclone by HPLC， and to investigate the influence of the relative correction factors. Methods： Chromatographic column is Kromail Eternity-5-C18 （4.6 mm×250 mm，5 μm）. Mobile phase is acetonitrile-phosphate solution (Take 8.1 g sodium lauryl sulfate and 1.6 g sodium dihydrogen phosphate， add 1 000 mL of water to dissolve it，use Phosphoric acid adjusts the pH value to 3.8)(41.5∶58.5).The flow rate is 1.0 mL·min-1. The detection wavelength is 303 nm and the column temperature is 30 ℃. Results： The peak sequence is impurity B、 impurity C、 catalyst (hereinafter referred to as impurity D) and impurity A，and the relative correction factors(relative to zopiclone) are 0.629，0.603，0.828，and 1.099. The seperation degree between impurities and Zopiclone can reach more than 1.5.The linear range of Zopiclone is： 7.033×10-2 μg·mL-1-3.246 0 μg·mL-1， the linear equation is： y=30.579x+0.578 3， and R2=0.999 8. Conclusion： This method can be used to control the related substances of Zopiclone，and the results on the influence of correction factors can also be used as a quality control reference.

Key words: font-size:medium, ">Zopiclone；related substances；Correction factor；High performance liquid chromatography（HPLC）；Evaluation of influence