首页|口服液体制剂中抑菌剂苯甲酸钠的检测及添加情况分析

口服液体制剂中抑菌剂苯甲酸钠的检测及添加情况分析

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

Oral Liquid PreparationsHPLC-DADBacteriostatSodium Benzoate

孙莉、张蓉、徐颜、吴敏、杜冬生

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安徽省芜湖市食品药品检验中心 安徽 芜湖 241001

安徽师范大学,安徽 芜湖 241001

口服液体制剂 HPLC-DAD 抑菌剂 苯甲酸钠

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
年,卷(期):2024.51(12)