高效液相色谱法测定硫酸罗通定注射液中罗通定的含量

HPLC Determination of Rotundine in Rotundine Sulfate Injection

目的:建立高效液相色谱法测定硫酸罗通定注射液中罗通定含量。方法:色谱柱为 C_(18)柱(250mm×4.6mm,5μm),流动相为乙腈-0.025mol·L^(-1)磷酸二氢钾水溶液-三乙胺(40:60:0.1)用50%磷酸调节 pH 至4.0,检测波长为280nm,流速为1.0 mL·min^(-1),柱温为35℃。结果:罗通定在30～270μg·m L^(-1)浓度范围内,峰面积与浓度呈良好的线性关系,r=1.0000,平均回收率为99.67%(n=6)。结论:方法简便、结果准确,适用于该产品的质量控制。

Objective： To establish a method for determination of rotundine in rotundine sulfate injection. Method： ：The column：Diamonsil C18 column （250 mm ×4. 6 mm,5 μm）. The mobile phase：acetonitrile -0. 025 mol · L^-1 potassium dihydrogen phosphate - triethylamine （40： 60： 0. 1 ,adjusted to pH =4. 0 by 50% phosphoric acid）. The detective wavelength was 280 nm. The flow rate：1. 0 mL · min^-1. Column temperature was at 35 ℃. Results： Standard curve was linear in the range of 30 -270 μg · mL^-1 and the correlation coefficient was 1. 0000. The average recovery was 99. 67% （n = 6 ）. Conclusion： The method is convenient, accurate and suitable for the quality control of rotundine in rotundine sulfate injection.