高效液相色谱法测定口服液体制剂中12种添加剂的含量

Determination of 12 additives in oral liquid preparations by HPLC

目的建立同时测定口服液体制剂中12种添加剂含量的高效液相色谱(HPLC)法。方法采用HPLC法对苯甲酸、山梨酸、糖精钠、脱氢乙酸、柠檬黄、日落黄、苋菜红、胭脂红、新红、酸性红、诱惑红及亮蓝进行测定,色谱柱为Waters XBridge C_(18)(250 mm×4.6 mm,5μm),流动相A为20 mmol·L^(-1)乙酸铵溶液,流动相B为甲醇,梯度洗脱,流速0.8 mL·min^(-1),柱温35℃,检测波长230 nm,进样体积10μL。结果各添加剂相应色谱峰分离效果较好,在0.5~20μg·mL^(-1)与峰面积呈良好线性关系(r=0.9992~0.9999),加样回收率为92.7%~108.1%,RSD为0.040%~1.6%。结论该方法简单、准确、重复性好,可适用于口服液体制剂中12种添加剂的检测。

Objective To determine 12 additives used in oral liquid preparations by HPLC.Methods Benzoic acid,sorbic acid,saccharin sodium,dehydroacetic acid,tartrazine,sunset yellow,amaranth,ponceau 4R,new red,carmoisine,allura red and brilliant blue were determined by HPLC.The column was Waters XBridge C_(18)(250 mm×4.6 mm,5μm).Mobile phase A was 20 mmol·L^(-1) ammonium acetate solution,mobile phase B was methanol,the elution program was gradient,the flow rate was 0.8 mL·min^(-1),the column temperature was 35℃,the detection wavelength was 230 nm,and the injection volume was 10μL.Results The chromatographic peaks of all additives were well separated and showed a good linearity at 0.5-20μg·mL^(-1)(r=0.9992-0.9999).The recovery of 12 additives was 92.7%-108.1%.The relative standard deviations varied at 0.040%-1.6%.Conclusion The method is simple,accurate and reproducible,and can be used to determine 12 additives in oral liquid preparations.