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  

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

作　　者：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] ZHOU Yuanhua;WU Liangyong;ZHANG Liwen;DONG Shunling;YAO Shangchen;XU Mingzhe;ZHANG Xianhua(Guangzhou Institute for Drug Control,Guangzhou Guangdong 510160,China;National Institutes for Food and Drug Control,Beijing 100050,China;Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China)

机构地区：[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

出　　处：《中国药物警戒》2023年第4期365-369,共5页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(SQ2022YFC3401205)。

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 C_(18)(250 mm×4.6 mm,5μm)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1.082~108.2μg·mL^(-1)(r=1.0000)和1.140~114.0μg·mL^(-1)(r=1.0000)范围内与峰面积呈良好的线性关系;检测限分别为0.2209和0.2021 ng,定量限分别为0.7364 ng和0.6738 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。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 C_(18)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 1.140~114.0μg·mL^(-1)(r=1.0000)and 1.082~108.2μg·mL^(-1)(r=1.0000),respectively.The limit of quantification(LOD)were 0.2209 ng and 0.2021 ng,and the limit of quantification(LOQ)were 0.6738 and 0.7364 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.

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 

分 类 号：R917[医药卫生—药物分析学]