【摘要】 目的 检查醋酸阿托西班注射液中潜在的二聚体杂质（Z35）等6个杂质。方法 采用飞诺美Phenomenex Gemini C₁₈ 110A（4.6 mm×250 mm，3 μm）色谱柱，流动相A为乙腈-甲醇-溶液Ⅰ（取纯水2000 mL，用三氟乙酸调pH至3.2）（15∶10∶75），流动相B为乙腈-甲醇（60∶40），进行梯度洗脱，柱温60℃，流速1.2 mL·min^-1，检测波长220 nm。结果 在该色谱条件下，6个杂质分离度符合要求，且空白溶液不干扰各杂质的检出；滤膜对杂质均无明显吸附作用；阿托西班及各杂质在50%～150%的限度浓度范围内与峰面积线性关系良好；各杂质的定量限和检测限均小于限度浓度水平，符合检测要求；重复性6份样品的各单杂和总杂含量变化绝对值均小于限度值的20%，符合精密度要求；加样回收率结果均在80%～120%内，方法准确度良好；供试品溶液及对照溶液在室温条件下放置24 h，各杂质检出无明显变化。结论 该方法简便、可行，可用于醋酸阿托西班注射液中有关物质检查。更多还原

【Abstract】 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-solutionⅠ （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.更多还原