中国药物警戒 ›› 2023, Vol. 20 ›› Issue (4): 365-369.
DOI: 10.19803/j.1672-8629.20230094

• 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

高效液相色谱法测定儿童口服液体制剂中抑菌剂苯甲酸钠和山梨酸钾的含量

周远华1, 伍良涌1, 张立雯1, 董顺玲1, 姚尚辰2#, 许明哲2,*, 张现化3   

  1. 1广州市药品检验所,广东 广州 510160;
    2中国食品药品检定研究院,北京 100050;
    3北京大学第三医院药剂科,北京 100191
  • 收稿日期:2023-02-23 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:周远华,男,硕士,副主任药师,药物质量分析。E-mail：yhchow@163.com
  • 基金资助:
    国家重点研发计划（SQ2022YFC3401205）

Determination of bactericidal sodium benzoate and potassium sorbate in pediatric oral liquid preparations by HPLC

ZHOU Yuanhua1, WU Liangyong1, ZHANG Liwen1, DONG Shunling1, YAO Shangchen2#, XU Mingzhe2,*, ZHANG Xianhua3   

  1. 1Guangzhou Institute for Drug Control, Guangzhou Guangdong 510160, China;
    2National Institutes for Food and Drug Control, Beijing 100050, China;
    3Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China
  • Received:2023-02-23 Online:2023-04-15 Published:2023-04-20

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摘要： 目的 建立高效液相色谱法筛查分析儿童口服液体制剂中抑菌剂苯甲酸钠和山梨酸钾。方法 采用Ecosil C18（250 mm×4.6 mm,5 μm）色谱柱,以0.02 mol·L-1乙酸铵溶液-乙腈（95∶5）为流动相,检测波长为225 nm,流速为1.0 mL·min-1。结果 苯甲酸钠和山梨酸钾分别在1.082~108.2 μg·mL-1（r=1.000 0）和1.140~114.0 μg·mL-1（r=1.000 0）范围内与峰面积呈良好的线性关系;检测限分别为0.220 9 和0.202 1 ng,定量限分别为0.736 4 ng和0.673 8 ng;平均回收率分别为100.4%和100.7%,RSD分别为0.4%（n=9）和0.5%（n=9）;分析15个品种共21批样品,检出的苯甲酸钠和山梨酸钾均在参考限度范围。结论 本实验建立的分析方法专属性强、灵敏度高、适用性好,可用于不同类型儿童口服液体制剂的质量控制。

关键词: 儿童, 口服液体制剂, 高效液相色谱法, 抑菌剂, 苯甲酸钠, 山梨酸钾, 含量

Abstract: Objective To establish an HPLC method for screening analysis of sodium benzoate and potassium sorbate in pediatric oral liquid preparations. Methods The chromatography was performed on Ecosil C18 column(250 mm×4.6 mm, 5μm) using. 0.02 mL·min-1 ammonium acetate solution-acetonitrile(95∶5, V/V) as mobile phase at a flow rate of 1.0 mL·min-1, and detected at 225 nm. Results Sodium benzoate and potassium sorbate showed a good linear relationship with the peak area in the range of 1.140~114.0 μg·mL-1（r=1.000 0）and 1.082~108.2 μg·mL-1（r=1.000 0）, respectively.The limit of quantification (LOD) were 0.220 9 ng and 0.202 1 ng, and the limit of quantification (LOQ) were 0.673 8 and 0.736 4 ng. The average recoveries were 100.4% with an RSD of 0.4% (n=9) and 100.7% with an RSD of 0.5% (n=9) .In 21 samples of 15 species, the sodium benzoate and potassium sorbate detected were within the reference limits. Conclusion The proposed HPLC method is specificity, accuracy and serviceability. It can be successfully applied in quality control of different types of pediatric oral liquid preparations.

Key words: paediatrics, liquid oral preparations, HPLC, bacteriostat, sodium benzoate, potassium sorbate, content

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