HPLC法测定醋酸阿托西班有关物质的研究

目的：建立HPLC法测定醋酸阿托西班的有关物质。方法色谱条件为：岛津液相LC-2010A（HT）；C18色谱柱（4.6 mm×250 mm，5μm），柱温40℃；流动相：流动相A：50 mmol/L的KH2PO4（稀TFA调节pH＝3.0），流动相B：乙腈：甲醇＝60：40；梯度洗脱；进样量20μL；流速1.0 mL/min，检测波长220 nm。结果由专属性实验可知，产生的杂峰与主峰分离，专属性良好。结论该方法简便、准确，系统适应性好，可以作为醋酸阿托西班有关物质的检测方法。

Studies of Determination of Relevant Materials of Atosiban Acetate by HPLC

Objective A HPLC method for determination of relevant materials of atosiban acetate was established.Methods The HPLC system was conducted as follows：Diamonsil C18 column（4.6 mm × 250 mm,5μm）;the column temperature was 40℃;mobile phase A：TFA in aqueous 50 mmol/L KH2PO4（pH=3.0）：mobile phase B：MeOH：MeCN=60：40;Gradient elution;The injection volume is 20μL;the flow rate was 1.0 mL/min;and the detector wavelength was 220 nm. Results It is known that the peak from the mixed with major peak separation.It had good specificity.Conclusion This method is simple、accurate,and the system applicability is good. It can be used as a atosiban relevant material test methods.