摘要
建立高效液相色谱法同时测定口服液体制剂中9种抑菌剂、抗氧剂和矫味剂的方法。样品经甲醇提取,0.22µm微孔滤膜过滤后取续滤液,色谱柱为CAPCELLPAK C_(18) MGⅡ(4.6 mm×250 mm,5µm),流动相为乙腈-甲醇-0.02 mol/L乙酸铵溶液,柱温35℃;流速1.0 mL/min,进样量5µL,检测波长280 nm,DAD检测器测定,定量分析采用外标法。在7.29~892.14µg/mL线性范围内,9种抑菌剂、抗氧剂和矫味剂呈良好的线性关系(r^(2)=0.99857~0.99996),回收率为96.52%~104.28%,相对标准偏差为0.37%~1.31%(n=6)。9种抑菌剂、抗氧化剂和矫味剂的最低检出浓度为0.07~2.00µg/mL,最低定量浓度为0.22~6.67µg/mL。本方法灵敏度高,准确性好,重复性好,稳定可靠,操作简单,可用于口服液体制剂中9种抑菌剂、抗氧化剂和矫味剂的检测。
A high performance liquid chromatography(HPLC)method for the determination of nine bacteriostat,antioxidant and flavor correctors in oral liquid preparations was established.The sample was extracted by methanol,filtered by 0.22µm millipore filter,finally the continued filtrate was obtained for analysis.The column of CAPCELLPAK C_(18) MGⅡ(4.6 mm×250 mm,5µm)was used with the mobile phase consisted of acetonitrile-methanol-0.02 mol/L ammonium acetate solution,the column temperature was 35℃.The flow rate was 1.0 mL/min,the injection volume was 5µL,the sample was detected at 280 nm by diode array detector(DAD).The external standard method was used to quantify the content.The test showed a good linearity in the range of 7.29 to 892.14µg/mL with a correlation coefficients of 0.99857 to 0.99996,the recoveries were 96.52 to 104.28%,the relative standard deviation was from 0.37%to 1.31%(n=6).The minimum detectable concentration was in the range of 0.07 to 2.00µg/mL,and the minimum quantitative concentration was in the range of 0.22 to 6.67µg/mL of nine bacteriostat,antioxidant and flavor correctors.The method has high sensitivity,good accuracy,stability and reliability,simple operation,rapid detection,and meets the daily inspection needs of nine bacteriostat,antioxidant and flavor correctors in oral liquid preparations.
作者
张铨
陈秀宽
伍国怡
黄海婷
刘艳云
ZHANG Quan;CHEN Xiukuan;WU Guoyi;HUANG Haiting;LIU Yanyun(Beihai Public Inspection and Testing Center,Guangxi Beihai 536000,China)
出处
《广州化工》
2025年第16期137-141,145,共6页
GuangZhou Chemical Industry
