【摘要】 目的 建立高效液相-纳克级（水凝粒子）激光计数检测器（HPLC-NQAD）联用法测定注射用兰索拉唑中助溶剂辅料葡甲胺的含量。方法 采用HPLC-NQAD联用，色谱柱使用CAPCELL PAK CR 1∶4（2.0 mm×150 mm,5 μm）；以流动相（A）(5 mmol·L^-1甲酸铵-2%乙腈)和流动相（B）(50 mmol·L^-1甲酸铵-50%乙腈)梯度洗脱；流速0.3 mL·min^-1；柱温40℃；进样量5μL;NQAD参数设定：蒸发温度35℃，雾化温度30℃，氮气压力30 psi。结果 供试品中的葡甲胺和其他成分能够良好分离，在1.0～100.0μg·mL^-1范围内，葡甲胺的浓度与峰面积呈良好线性关系，相关系数r=0.999 8，平均回收率为99.96%，精密度RSD为1.01%。结论 该方法结果准确，重复性好，可实现注射用兰索拉唑中无紫外吸收辅料葡甲胺的高灵敏检测。更多还原

【Abstract】 Objective To establish a method for determining the content of meglumine in lansoprazole for injection based on HPLC-NQAD. Methods The HPLC-NQAD method was established on a CAPCELL PAK CR 1:4 column（2.0 mm×150 mm, 5 μm） by using a mobile phase of 5 mmol·L^-1 ammonium formate-2% acetonitrile（A） and 50 mmol·L^-1 ammonium formate-50% acetonitrile（B） under gradient elution at a flow rate of 0.3 mL·min^-1. The column temperature was 40℃, injection volume was 5 μL, NQAD evaporation temperature was 35℃, atomization temperature was 30℃, and nitrogen pressure was 30 psi. Results Meglumine was separated completely in the test solution. The calibration curve was linear within the range of 1.0 μg·mL^-1 to 100.0 μg·mL^-1 for meglumine（r = 0.999 8）. The average recovery was 99.96%, and the RSD was 1.01%. Conclusion This method has proved to be simple, accurate, sensitive and reliable. It can be used for the determination of meglumine in lansoprazole for injection.更多还原