HPLC-PDA内标法检测康尔心胶囊十二种非法添加色素

HPLC-PDA Internal Standard Method to Detect Twelve Illegal Pigments in Kang Erxin Capsules

目的：以姜黄素为内标物,建立HPLC-PDA内标法检测康尔心胶囊非法添加色素胭脂红、酸性红73、诱惑红、赤藓红、酸性橙II、酸性金黄、金胺O、日落黄、苏丹红I、苏丹红II、苏丹黄、苏丹橙G的方法。方法：样品以60%乙醇超声提取,以乙腈-0.02 mol·L-1乙酸铵溶液为流动相进行梯度洗脱,二极管阵列检测器检测。结果：该方法检出限为0.56~16.46 mg·Kg-1,加样回收率为95.54%~104.46%;市售康尔心胶囊18批次均未检出12种非法色素。结论：本实验采用姜黄素为内标物,HPLC-PDA法检测康尔心胶囊12种常用的非法添加色素,方法简单、准确、快速,可以为制药企业或药品监督管理部门控制康尔心胶囊的质量提供参考。

Objective： To establish HPLC-PDA internal standard method with curcumin as internal standard to detect illegally added pigments carmine, acid red 73, allura red, erythrosine, acid orange II, metanil yellow, auramine O, sunset yellow, Sudan I, Sudan II, Sudan yellow and Sudan orange G. Methods： The sample was ultrasonically extracted with 60% ethanol and treated with acetonitrile-0.02 mol·L-1 ammonium acetate solution as mobile phase in gradient elution. The dual wavelength detection diode array detector was used for detection. Results： The detection limit of this method was 0.56-16.46 mg·Kg-1, the recovery was 95.54%-104.46%. None of the 18 batches of commercial Kang Erxin capsules were detected with the 12 kinds of illegally added pigments. Conclusion： This experiment used curcumin as internal standard. The HPLC-PDA method for detection of 12 kinds of commonly used illegally added pigments in Kang Erxin capsules was simple, accurate and fast, which can give some reference for the pharmaceutical enterprises or the pharmaceutical supervisory and administrative departments to control the quality of Kang Erxin capsules.