高效液相-纳克级激光计数检测器联用法测定注射用兰索拉唑中葡甲胺的含量  

Determination of meglumine in lansoprazole for injection by HPLC-NQAD

作　　者：杨茜 惠艳春 王晨[2] 张现化[3] 许明哲[2] YANG Qian;HUI Yanchun;WANG Chen;ZHANG Xianhua;XU Mingzhe(Sanyo fine trading Co.,LTD,Beijing 100022,China;National Institutes for Food and Drug Control,Beijing 102629,China;Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China)

机构地区：[1]三耀精细化工品销售(北京)有限公司,北京100022 [2]中国食品药品检定研究院,北京102629 [3]北京大学第三医院药剂科,北京100191

出　　处：《中国药物警戒》2023年第4期361-364,共4页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(SQ2022YFC3401205)。

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,5μm);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=0.9998,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。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,5μm)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 5μL,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 1.0μg·mL^(-1)to 100.0μg·mL^(-1)for meglumine(r=0.9998).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.

关 键 词：高效液相-纳克级(水凝粒子)激光计数检测器联用法 兰索拉唑 注射剂 葡甲胺 助溶剂 含量测定 

分 类 号：R917[医药卫生—药物分析学]