Method for detecting potential genotoxic impurities of esomeprazole sodium

The invention discloses a method for detecting potential genotoxic impurities of esomeprazole sodium. The method comprises the following steps: (1) preparing an esomeprazole sodium test sample solution; (2) preparing an impurity control sample solution, the impurity being selected from at least one of 2, 3, 5-trimethylpyridine nitrogen oxide, 2, 3, 5-trimethyl-4-nitropyridine nitrogen oxide, 2, 3,5-trimethyl-4-methoxypyridine nitrogen oxide and 2-chloromethyl-3, 5-dimethyl-4-methoxypyridine nitrogen oxide; (3) detecting the test sample and the control sample by adopting high performance liquid chromatography, and taking a phosphate buffer solution and acetonitrile as mobile phases according to a volume ratio of 58-68: 42-32. According to the method, potential genotoxic impurities in the esomeprazole sodium can be effectively separated and quantitatively detected, conditions are simple, the separation degree is high, and the safety and effectiveness of the esomeprazole sodium can be further improved. 本发明公开了一种艾