降糖类中成药和保健食品中13种非法添加成分检测方法改进

Improvement of Detection Method for 13 Illegal Components Added into Anti-Diabetic Chinese Patent Medicine and Health Food

目的建立测定降糖类中成药中13种非法添加成分的高效液相色谱法。方法色谱柱采用Agilent Zorbax SB-C18柱(150 mm×2.1 mm,1.8μm),以乙腈为流动相(A)、0.02 mol/L乙酸铵溶液为流动相(B)梯度洗脱,流速为0.2mL/min,检测波长为235 nm,柱温为35℃。结果13种降糖药物分离度良好,质量浓度线性范围为0.313 8~59.93μg/m L,相关系数在0.999以上;回收率为94.13%~104.53%,RSD为1.09%~6.82%(n=8)。结论该方法简便准确,重复性好,检出限低,能有效控制降糖类中成药和保健食品的质量。

Objective To establish an HPLC method for the determination of 13 illegal components added into anti-diabetic Chinese patent medicine and health food. Methods The chromatographic column was Agilent Zorbax SB-C18 column( 150 mm × 2. 1 mm,1. 8 μm),the mobile phase A was acetonitrile,the mobile phase B was 0. 02 mol/L ammonium acetate solution with gradient elution,the flow rate was 0. 2 m L/min,the detection wavelength was 235 nm and the column temperature was 35 ℃. Results For 13 anti-diabetic drugs,the separation was good,the linear range was 0. 313 8-59. 93 μg/m L,the correlation coefficient was higher than 0. 999,the recovery was in the range of 94. 13%-104. 53%,RSD was in the range of 1. 09%-6. 82%( n = 8). Conclusion The method is simple,accurate,and reproducible,it has low detection limit and can effectively control the quality of anti-diabetic Chinese patent medicines and health food.