Content Determination of Oxytocin Injection by HPLC Gradient Elution Method
OBJECTIVE To establish an HPLC method for determination of content of oxytocin injection.METHODS An Welch Xtimate® C18(150 mm×4.6 mm,3 μm)column was used with the detection wavelength of 220 nm,and the flow rate of 1.0 mL·min-1,the column temperature was set at 40 ℃.The content determination of oxytocin injection was performed using acetonitrile-water-phosphate solution(0.2 mol·L-1 anhydrous dihydrogen phosphate solution,adjusted the pH value to 6.2 with sodium hydroxide solution,15∶70∶15)as mobile phase A,acetonitrile-water-phosphate solution(0.2 mol·L-1 anhydrous dihydrogen phosphate solution,adjusted the pH value to 6.2 with sodium hydroxide solution,70∶15∶15)as mobile phase B.Gradient elution was used.RESULTS Blank solvent and blank excipient solution did not interfere with the determination of oxytocin.The linear ranges of the content of oxytocin injection was 2.007 8-20.077 8 IU·mL-1(r=0.999 9),the average recovery was 98.54％(RSD of 1.34％).The quantification limit and detection limit were 8.393 0 ng·mL-1and 2.517 9 ng·mL-1.The test solution was stable at room temperature within 24 h.CONCLUSION The method is accurate,simple,reliable,and can be used for the determination of the content in oxytocin injection.
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