云南化工2024,Vol.51Issue(12) :112-116.DOI:10.3969/j.issn.1004-275X.2024.12.22

口服液体制剂中抑菌剂苯甲酸钠的检测及添加情况分析

Detection of Bactericidal Sodium Benzoate in Oral Liquid Preparations and the Addition Analysis

孙莉 张蓉 徐颜 吴敏 杜冬生
云南化工2024,Vol.51Issue(12) :112-116.DOI:10.3969/j.issn.1004-275X.2024.12.22

口服液体制剂中抑菌剂苯甲酸钠的检测及添加情况分析

Detection of Bactericidal Sodium Benzoate in Oral Liquid Preparations and the Addition Analysis

孙莉 1张蓉 1徐颜 1吴敏 1杜冬生2
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作者信息

  • 1. 安徽省芜湖市食品药品检验中心 安徽 芜湖 241001
  • 2. 安徽师范大学,安徽 芜湖 241001
  • 折叠

摘要

(目的)建立口服液体制剂中苯甲酸钠的HPLC-DAD定量检测方法,并对多批次样品的检出情况进行分析.(方法)采用 HPLC-DAD 法,以 Agilent ZORAX Eclipse XDB C18(250 mm × ø 4.6 mm,5 μm)为色谱柱,甲醇-0.02mol/L磷酸二氢钠溶液(用磷酸调节pH值为3.7,体积比30∶70)为流动相,柱温30 ℃,检测波长为228 nm,进样量:10 μL.(结果)苯甲酸钠在0.0131~0.261 mg·mL-1(r=1.0000)范围内峰面积与质量浓度线性关系良好;检测限为0.105 μg·mL-1;定量限为0.209μg·mL-1.基质比较复杂的糖浆剂和合剂的平均回收率分别为98.3%和101.6%,RSD分别为0.82%(n=9)和0.76%(n=9);分析56个品种共105批样品,检出的苯甲酸钠含量差异较大.(结论)该方法简便、专属性强、灵敏度高,可用于口服液体制剂中苯甲酸钠的定量筛查.

Abstract

(Objective)An analysis method was developed to determine sodium benzoate in oral liquid prepaertions,and the detection status of multiple batches of samples was also analyzed.(Methods)The HPLC-DAD method was adopted and separated by an Agilent ZORAX Eclipse XDB C18(250 mm × ø4.6 mm,5 μm)column with Methanol-0.02 mol/L sodium dihydrogen phosphate solution(adjusted pH to 3.7 with phos-phates)(30∶70,V/V)as the mobile phase.The column temperature was 30 ℃,the detection wavelength was 228 nm And injection quantity was 10 μL.(Results)The peak area and the concentration of sodium benzoate in 0.0131-0.261 mg·mL-1(r=1.0000);the limit of detection is 0.105 μg·mL-1 and the limit of quantification is 0.209 μ g·mL-1.The average recovery of complex syrup and mixture was 98.3%and 101.6%,and the RSD was 0.82%(n=9)and 0.76%(n=9),respectively;for 105 batches of 56 varieties,the content of sodium benzoate de-tected varied greatly.(Conclusion)The method is simple,rapid,specific and sensitive.It can be used for the quantitative screening of sodium benzoate in oral liquid preparations.

关键词

口服液体制剂/HPLC-DAD/抑菌剂/苯甲酸钠

Key words

Oral Liquid Preparations/HPLC-DAD/Bacteriostat/Sodium Benzoate

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出版年

2024
云南化工
云南省化工研究院 云天化集团有限责任公司 云南煤化工集团有限公司 云南省化学化工学会

云南化工

影响因子:0.272
ISSN:1004-275X
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