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

作　　者：孙莉 张蓉 徐颜 吴敏 杜冬生 Sun Li;Zhang Rong;Xu Yan;Wu Min;Du Dongsheng(Wuhu Institute for Food and Drug Control,Wuhu 241000,China;Anhui Normal University,Wuhu 241000,China)

机构地区：[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

出　　处：《云南化工》2024年第12期112-116,共5页Yunnan Chemical Technology

基　　金：安徽省药品监督管理局科技创新项目(AHYJ-KJ-202326)。

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 C_(18)(250 mm×φ4.6 mm,5μm)为色谱柱,甲醇-0.02 mol/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:10μL。(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0.105μg·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。(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 C_(18)(250 mm×∅4.6 mm,5μm)column with Methanol-0.02 mol/L sodium dihydrogen phosphate solution(adjusted pH to 3.7 with phosphates)(30∶70,V/V)as the mobile phase.The column temperature was 30℃,the detection wavelength was 228 nm And injection quantity was 10μL.(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 0.105μg·mL^(-1)and the limit of quantification is 0.209μg·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 detected 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 

分 类 号：R927[医药卫生—药学] TS202[轻工技术与工程—食品科学]