Detection of 6 impurities in atosiban acetate injection by HPLC
Objective To examine 6 impurities including potential dimer impurity(Z35)in atosiban acetate injection.Methods Phenomenex Gemini C18 110A(4.6 mm∶250 mm,3 μm)chromatographic column was used.Mobile phase A was acetonitrile-methanol-solution Ⅰ(2000 mL of pure water was used,and the pH was adjusted to 3.2 with trifluoroacetic acid)(15∶10∶75),while mobile phase B was acetonitrile-methanol(60∶40).Gradient elution was performed,the column temperature was 60 ℃,the flow rate was 1.2 mL·min-1,and the detection wavelength was 220 nm.Results Under the chromatographic conditions,the separation degree of the 6 impurities met the requirements,and the blank solution did not interfere with the detection of each impurity.The filter membrane had no obvious adsorption effect on the impurities.Atosiban and each impurity had a good linear relationship at 50％～150％.Both the quantification limit and detection limit of each impurity were lower than the limit concentration level,which met the detection requirements.The absolute value of each single impurity and total impurity content change of the 6 samples were less than 20％of the limit value,which also met the precision requirements.The sample recovery ranged at 80％～120％,and the accuracy of the method was good.The test solution and the control solution were placed at room temperature for 24 h,without significant change in the content of each impurity.Conclusion The method is simple and feasible,and can be used for the detection of related substances in atosiban acetate injection by HPLC.
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