Safety Monitoring

Determination of seven impurities in omeprazole sodium for injection by main component self-compare method

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  • Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050011, China

Revised date: 2022-06-20

  Online published: 2024-06-24

Abstract

Objective: To establish a RP-HPLC method for determination of seven impurities in omeprazole sodium for injection by main component self-compare method. Methods: The separation was performed on Waters XBridge C8 column (250 mm×4.6 mm, 5 μm) with gradient elution, Using phosphate buffer (pH 7.0)-acetonitrile as the mobile phase. The flow rate was 1.0 mL·min-1, the column temperature was 25 ℃, the detection wavelength was 280 nm. And relative correction factors were used to calculate the content of seven known impurities. Results: Under the selected liquid chromatographic conditions, the peak sequence of the principal component and the seven known impurities was impurites Ⅱ, Ⅳ, Ⅷ, Ⅴ, omeprazole, impurity Ⅰ, Ⅲ and Ⅸ/Ⅹ, the resolution between each peak was in line with the regulations, and the detection limits of each impurity were 1.0 ng, 0.3 ng, 0.7 ng, 0.7 ng, 2.2 ng, 2.7 ng and 1.8 ng, separately. Impurity Ⅲ and impurity Ⅳ were detected in all three batches of samples. The results obtained by main component self-compare method were no significant differentiation with those obtained by external standard method, and the difference between the two methods was 0.02% at most. Conclusion: The method has the advantages of simple operation, low cost, strong practicability and specificity, and could be used for the impurity inspection of omeprazole sodium for injection.

Cite this article

ZHANG Yi-hua, TIAN Xiao-tong, WANG Liu, JIN Lin, ZHAO Wan-ting, GAO Yan-xia . Determination of seven impurities in omeprazole sodium for injection by main component self-compare method[J]. Chinese Journal of Pharmaceutical Analysis, 2022 , 42(7) : 1201 -1208 . DOI: 10.16155/j.0254-1793.2022.07.13

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