基于波长切换法测定参三七伤药胶囊(片)中松香酸和苏丹红Ⅳ的含量  

Determination of Abietic Acid and SudanⅣin Shensanqi Shangyao Capsules(Tablets)by HPLC Wavelength Switching Method

作　　者：戴丽娜 刘益庆 陈泳君 Dai Lina;Liu Yiqing;Chen Yongjun(Lianyungang Food and Drug Inspection Center,Jiangsu Lianyungang 222006,China)

机构地区：[1]连云港市食品药品检验检测中心,江苏连云港222006

出　　处：《中国药师》2022年第1期150-154,共5页China Pharmacist

基　　金：江苏省市场监督管理局科技计划项目(编号:KJ196054)。

摘　　要：目的:建立HPLC-DAD波长切换法同时测定参三七伤药胶囊(片)中非法添加松香酸和苏丹红Ⅳ的含量。方法:Phenomenex Gemini C_(18)柱(250 mm×4.6 mm,5μm);以乙腈-0.1%甲酸水溶液为流动相,梯度洗脱;检测波长:0~48 min,260 nm(松香酸);48~70 min,520 nm(苏丹红Ⅳ),流速:1 ml·min^(-1),柱温:20℃,进样量:10μl。结果:松香酸在5.14~514.50μg·ml^(-1)、苏丹红Ⅳ在0.05~5.02μg·ml^(-1)浓度范围内与峰面积线性关系良好(r>0.999);加样回收率分别为99.53%,99.60%,RSD分别为0.43%,0.72%(n=9)。结论:该方法的专属性、准确度、耐用性均表现良好,适合作为测定参三七伤药胶囊(片)中非法添加松香酸和苏丹红Ⅳ的定量分析方法。Objective:To establish an HPLC-DAD method for the determination of abietic acid and Sudan IV illegally added to Shensanqi Shangyao capsules(tablets)by using HPLC wavelength switching method.Methods:The HPLC method was conducted on a Phenomenex Gemini C_(18)column(250 mm×4.6 mm,5μm);mobile phase was acetonitrile(A)-0.1%formic acid(B)in gradient mode.The detection wavelength was set as follows:0-48 min,260 nm(abietic acid);48-70 min,520 nm(SudanⅣ).The flow rate was 1.0 ml·min^(-1);the column temperature was 20℃with the injection volume of 10μl.Results:Abietic acid was exhibited a good linearity within the concentration range of 5.14-514.50μg·ml^(-1)and SudanⅣwithin the concentration range of 0.05-5.02μg·ml^(-1)(r>0.999)had good linear relationship as well.The recoveries were 99.53%and 99.60%,and the RSDs were 0.43%and 0.72%(n=9),respectively.Conclusion:The method can carry out the qualitative and quantitative analysis with high specificity,accuracy and durability,and is suitable for quantitative analysis of abietic acid and SudanⅣillegally added to Shensanqi Shangyao capsules(tablets).

关 键 词：参三七伤药胶囊(片) 松香酸 苏丹红Ⅳ 高效液相色谱-二极管阵列检测器 波长切换法 

分 类 号：R927.2[医药卫生—药学]