红花清肝十三味丸中非法染色剂808猩红的测定  

Detection of illegally added 808 scarlet in Honghua Qinggan Shisanwei pills

作　　者：王秋实 吴琦 赵猛 李玲 王婷婷 陈乃江 WANG Qiu-shi;WU Qi;ZHAO Meng;LI Ling;WANG Ting-ting;CHEN Nai-jiang(Food and Drug Control Center of Lianyungang,Lianyungang Jiangsu 222000)

机构地区：[1]江苏省连云港市食品药品检验检测中心,江苏连云港222000

出　　处：《中南药学》2025年第4期1105-1108,共4页Central South Pharmacy

基　　金：国家药品监督管理局药品补充检验方法(No.2022019)。

摘　　要：目的建立红花清肝十三味丸中非法染色剂808猩红的检测方法。方法采用高效液相色谱法,色谱柱:Phenomenex Gemini C_(18)柱(250 mm×4.6 mm,5µm);流动相:乙腈-0.1%甲酸(80∶20);检测波长为518 nm;柱温为30℃;进样量:10μL;流速:1.0 mL·min^(-1)。液质联用采用色谱柱:Poroshell 120 EC-C_(18)(50 mm×3.0 mm,2.7µm),流动相:乙腈-0.1%甲酸(80∶20);进样量:1µL;流速:0.2 mL·min^(-1)。ESI^(+)扫描。结果含量测定显示808猩红在4.525~226.2 ng(r=0.9992)内与峰面积呈现良好的线性关系,平均回收率为98.67%,RSD=1.2%(n=6)。结论本法操作简便,专属性强,重现性好,可用于红花清肝十三味丸的质量控制。Objective To establish a method for the detection of illegally added 808 scarlet in Honghua Qinggan Shisanwei pills.Methods HPLC method with a Phenomenex Gemini C_(18)(250 mm×4.6-1 mm,5µm)was used.The injection volume was 10μL at the flow rate of 1.0 mL·min with acetonitrile-0.1%formic acid(80∶20).The wavelength was 518 nm and the column temperature was 30℃.HPLC-QTOF-MS was performed on an Poroshell 120 EC-C_(18)(50 mm×3.0 mm,2.7µm);positive ESI mode;acetonitrile-0.1%formic acid(80∶20)was used as the mobile phase.The injection volume was 1μL.The flow rate was 0.2 mL·min^(-1).Results Good linearity was found between 808 scarlet and peak area at 4.525~226.2 ng(r=0.9992),with the average recovery of 98.67%,RSD of 1.2%(n=6).Conclusion The presented procedure has easy operation,and good specificity and repeatability,which can be used for the quality control of Honghua Qinggan Shisanwei pills.

关 键 词：红花清肝十三味丸 808猩红 含量测定 HPLC-QTOF-MS 高效液相色谱法 

分 类 号：O657.7[理学—分析化学] R927.2[理学—化学]