OBJECTIVE: To establish a method for simultaneous determination of impurity E, impurity Ⅰ and impurity Ⅳ in crude drug and preparation of esomeprazole sodium. METHODS: LC-MS/MS method was adopted. The separation was performed on Agela VenusiL MP C18 column with mobile phase consisted of acetonitrile-water (gradient elution) at the flow rate of 0.2 mL/min. The column temperature was 35 ℃, and the sample size was 1 μL; analytes were analyzed by electro-spray ionization (ESI) in the multiple reaction monitoring mode, negative ion. The precursors of production transitions m/z 360.1→194.0 (impurity E), m/z 375.8→210.7 (impurity Ⅰ), m/z 330.2→312.1 (impurity Ⅳ) were used to measure impurity. RESULTS: The linear range of impurity E, impurity Ⅰ and impurity Ⅳ were 0.001 26-0.044 80 μg/mL (r=0.994 7), 0.001 34-0.045 2 μg/mL (r=0.992 8) and 0.018 9-1.260 00 μg/mL (r=0.991 4). The limit of quantitation were 0.001 26, 0.001 34, 0.018 9 μg/mL; the detection limits were 0.000 41, 0.000 44, 0.006 3 μg/mL. RSDs of precision and reproducibility tests were all lower than 4%; RSDs of stability tests of impurity E and impurity Ⅰ were all lower than 10%(n=5), and that of impurity Ⅳ was higher than 15% (n=7). The average recoveries were 87.69%-100.72% (RSD=4.29%, n=9), 90.04%-100.63%(RSD=3.67%,n=9)and 93.58%-101.86%(RSD=2.66%,n=9). CONCLUSIONS: The method is accurate, rapid, sensitive, selective and suitable for the content determination of 3 impurities in crude drug and preparation of esomeprazole sodium.