UPLC梯度洗脱法测定注射用阿洛西林钠中有关物质

发布时间：2018-03-24 22:27

  本文选题：超高效液相色谱法　切入点：阿洛西林钠　出处：《中国抗生素杂志》2015年03期

【摘要】：目的探索建立合适的超高效液相色谱-梯度洗脱法检测注射用阿洛西林钠的有关物质,采用LC-MS法对注射用阿洛西林钠的部分有关物质进行鉴定。方法色谱柱为ACQUITY UPLC BEH C18,2.1mm×100mm,1.7mm;流动相A为10mmol/L甲酸铵溶液(用氨水调节p H值至6.5),流动相B为8mmol/L甲酸铵溶液(乙腈/水=200/50);柱温为40℃;检测波长为210nm;流速为0.43m L/min。结果阿洛西林钠主峰与其相关物质峰分离良好,检出杂质数量远多于中国药典2010年版二部各论方法;在0.3~90μg/m L范围内阿洛西林呈良好的线性关系(r2=0.9999),方法的检测限为0.1μg/m L,重复性RSD为0.61%(n=6)。结论改进的UPLC方法的色谱性能明显优于现行标准方法,且准确、简便、灵敏,更适用于注射用阿洛西林钠的有关物质检测。
[Abstract]:Objective to establish a suitable ultra-high performance liquid chromatography-gradient elution method for the determination of related substances of aloxicillin sodium for injection. LC-MS method was used to identify some related substances of aloxicillin sodium for injection. Methods the chromatographic column was ACQUITY UPLC BEH C182.1 mm 脳 100mm ~ 1.7mm, the mobile phase A was ammonium 10mmol/L formate solution (adjust pH value to 6.5) with ammonia water, and the mobile phase B was 8mmol/L ammonium formate solution (B). The column temperature is 40 鈩，

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