Determination of Organic Impurities in Oxytocin Injection by HPLC
Objective:To establish an HPLC method for the determination of organic impurities in oxytocin injection.Methods:Chromatographic column:GL Sciences InertSustain C18,250 mm×4.6 mm,5.0 μm;The mobile phase A consists of a pH 5.0 phosphate buffer solution-acetonitrile(95:5),and mobile phase B is acetonitrile,employing a linear gradient elution at a flow rate of 1.0 mL/min;The detection wavelength was 220 nm,the column temperature was 40℃,and the sampling injection was 100 µL.Results:Under the chromatographic conditions in this article,the blank excipients did not interfere,oxytocin and 8 specific impurities were well separated,showing a good linear relationship.The detection limits of impurity A,B,D,E,F,G,I and J was 0.43 ng～0.48 ng,and the quantitation limits of them was 0.96 ng～1.56 ng.Conclusion:The method can effectively separate oxytocin and its 8 impurities,with high sensitivity and strong specificity.The method is suitable for determining the organic impurities in oxytocin injection.
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