中国药物警戒 ›› 2023, Vol. 20 ›› Issue (4): 361-364.
DOI: 10.19803/j.1672-8629.20230045

• 前沿分析方法在药品质量评价中的应用专栏 • 上一篇    下一篇

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

杨茜1, 惠艳春1, 王晨2#, 张现化3, 许明哲2,*   

  1. 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
  • 收稿日期:2023-02-03 出版日期:2023-04-15 发布日期:2023-04-20
  • 通讯作者: *许明哲,男,博士,主任药师,药物质量评价与药事管理。E-mail：xumzhe@nifdc.org.cn;#为共同通信作者。
  • 作者简介:杨茜,女,硕士,工程师,液相液质分析方法建立。
  • 基金资助:
    国家重点研发计划（SQ2022YFC3401205）

Determination of meglumine in lansoprazole for injection by HPLC-NQAD

YANG Qian1, HUI Yanchun1, WANG Chen2#, ZHANG Xianhua3, XU Mingzhe2,*   

  1. 1Sanyo fine trading Co., LTD, Beijing 100022, China;
    2National Institutes for Food and Drug Control, Beijing 102629, China;
    3Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China
  • Received:2023-02-03 Online:2023-04-15 Published:2023-04-20

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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5 μL;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 ~100.0 µg·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。

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

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.

Key words: HPLC-NQAD, lansoprazole, injection, meglumine, cosolvent, determination

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