中国药物警戒 ›› 2022, Vol. 19 ›› Issue (9): 959-961.
DOI: 10.19803/j.1672-8629.2022.09.06

• 基础与临床研究 • 上一篇    下一篇

高效液相-电喷雾检测法测定赖氨肌醇维B12口服溶液中肌醇的含量

钱忠义1, 葛薇薇1, 仇雅静1,*, 许明哲2,#   

  1. 1泰州市药品检验院,江苏 泰州 225300;
    2中国食品药品检定研究院,北京 102629
  • 收稿日期:2021-03-24 出版日期:2022-09-15 发布日期:2022-09-16
  • 通讯作者: *仇雅静,女,本科,主任中药师,药品质量控制和标准研究。E-mail：1908368215@qq.com。#为共同通信作者。
  • 作者简介:钱忠义,男,本科,副主任药师,药物分析和化妆品检验。
  • 基金资助:
    重大新药创制国家科技重大专项课题2017年度（2017zx09101001）

Determination of inositol in oral solution B12 lysine inositol by HPLC-CAD

QIAN Zhongyi1, GE Weiwei1, QIU Yajing1,*, XU Mingzhe2,#   

  1. 1Taizhou Institute for Drug Control, Taizhou Jiangsu 225300, China;
    2National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2021-03-24 Online:2022-09-15 Published:2022-09-16

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摘要： 目的 建立赖氨肌醇维B12口服溶液中肌醇含量测定的高效液相-电喷雾检测法。方法 采用Agilent ZORBAX NH2色谱柱（4.6 mm×250 mm, 5μm）,流动相为乙腈-0.5%乙醇水溶液（90:10）,流速为1.0 mL·min-1;采用电喷雾检测器,雾化温度为55℃;幂率为2.0;采样频率为5 Hz;过滤常数为10 s。结果 肌醇与蔗糖及其他峰之间均达到基线分离;肌醇质量浓度在0.090 8~1.815 mg·mL-1范围内线性关系良好（r>0.999）,线性方程为Y=331.85X-28.812,检测限为3μg·mL-1,定量限为13μg·mL-1。肌醇含量80%、100%和120%肌醇制备得到高、中、低对照品3种浓度的回收率分别为99.4%、101.2%和101.6%。结论 所建方法专属性好、灵敏度高、操作简单,适合作为赖氨肌醇维B12口服溶液中肌醇含量测定的方法。

关键词: 赖氨肌醇维B12口服溶液, 肌醇, 高压液相, 电喷雾检测器, 含量测定

Abstract: Objective To establish an HPLC-CAD method for the determination of inositol in oral solution B12. Methods The Agilent Zorbax NH2 (4.6 mm×250 mm, 5 μm) column was used. The mobile phase consisted of acetonitrile-0.5% ethanol solution (90:10), and the flow rate was 1.0 mL·min-1. The charged aerosol detector (CAD） was used at an atomization temperature of 55℃, a power rate of 2.0, a sampling frequency of 5 Hz with a filtration constant of 10 s. Results Baseline separation was achieved between inositol, sucrose and other peaks. When the concentrations of inositol ranged from 0.090 8 to 1.815 mL·min-1, the linear equation was Y=331.85X -28.812, the detection limit was 3 μg·mL-1, with a quantitative limit of 13 μg·mL-1. The recoveries of 80%, 100% and 120% inositol reference substances were 99.4%, 101.2% and 101.6%, respectively. Conclusion This method is highly specific, sensitive and user-friendly, which can be used for the determination of inositol content in oral solution B12.

Key words: oral solution B12 lysine inositol, inositol, HPLC, charged aerosol detector, determination

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