摘要：目的 建立测定醋酸阿托西班注射液含量的UPLC法并进行方法学验证。方法 色谱条件：以0.05mol/L的磷酸盐缓冲液pH2.3为流动相A，乙腈为流动相B，梯度洗脱；进样量2μl，流速0.4ml/min，检测波长215nm。结果：在0.75～2.25μg范围内与主峰面积呈良好的线性关系(R2=0.9999)；空白溶剂对该法无干扰；重复性RSD为0.1%，中间精密度RSD为0.2%；溶液稳定性实验RSD为0.3%；不同加标量的平均回收率为100.10%；耐用性实验结果显示各条件检测结果RSD在1.0%以内；采用HPLC与UPLC对3批样品的含量测定进行对比，两法相对偏差均未超过0.5%。结论 UPLC法快速、简便、准确、专属性强，适用于醋酸阿托西班注射液含量测定。

    关键词 醋酸阿托西班注射液 UPLC 含量

    【中图分类号】186.3 【文献标识码】A 【文章编号】2107-2306(2019)02-135-02

    Abstract： Objective Establish the UPLC method for assay of Atosiban Acetate Injection and carry out the methodology validation. Method Chromatographic Conditions： 0.05 mol/L phosphate buffer solution pH 2.3 was used as mobile phase A and acetonitrile was used as mobile phase B to carry out the gradient elution. Injection volume was 2 μl. Flow rate was 0.4 ml/min. Detection wavelength was 215 nm. Results： There was a good linear relationship with the area of the principal peak within the range of 0.75～2.25 μg (R2=0.9999). The blank solvent had no interference with this method. The RSD of repeatability was 0.1% ......