Esomeprazole sodium is a specific inhibitor of proton pumps in gastric wall cells, reducing gastric acid secretion and treating gastric acid related diseases. It is a very common drug for treating gastrointestinal diseases, and the drug efficacy and effects of Esomeprazole are very extensive.

Esomeprazole sodium is widely used in clinical practice to treat digestive ulcers, reflux esophagitis, and Helicobacter pylori. As it belongs to proton pump inhibitors, it can specifically act on gastric mucosal parietal cells, reversibly inhibiting the activity of proton pumps in parietal cells, thereby inhibiting gastric acid secretion. These drugs have a stronger and more persistent inhibitory effect on gastric acid secretion than H2 receptor antagonists.

usePOSITISIL® ODS-3 3um 4.6X100mmThe chromatographic column can meet the experimental requirements for impurity limit detection of omeprazole sodium by referring to the high-performance liquid chromatography method in the Chinese Pharmacopoeia.

test solutionTake an appropriate amount of this product, weigh it accurately, dissolve it in mobile phase A and dilute it quantitatively to prepare a solution containing approximately 0.2mg per 1ml.

System suitability solutionTake appropriate amounts of omeprazole reference substance and impurity I reference substance respectively, dissolve and dilute them in mobile phase A to prepare a mixed solution containing approximately 0.02mg per 1ml.

sensitivity solutionAccurately measure an appropriate amount of the test solution and dilute it quantitatively with mobile phase A to prepare a solution containing approximately 0.2 μ g per 1ml.

Chromatographic conditions

chromatographic columnPOSITIVE ® ODS-3 3um 4.6X100mm

Using water phosphate buffer solution (pH 7.6) (containing 0.0052mol of sodium dihydrogen phosphate and 0.032mol of disodium hydrogen phosphate per 1000ml) - acetonitrile (80:10:10)Mobile phase A,Acetonitrile phosphate buffer solution (pH 7.6) - water (80:1:19)Mobile phase BPerform linear gradient elution according to the table below; The detection wavelength is 302nm and the injection volume is 20 μ l.