论文部分内容阅读
目的:建立以HPLC法测定酚磺乙胺注射液含量的方法。方法:色谱柱为氨基键合硅胶柱(5μm,4.6mm×250mm);流动相为甲醇-0.2%磷酸二氢钾溶液(10:90);流速为1.0mL/min;检测波长为223nm,柱温为25℃。结果:酚磺乙胺在50.1～801.6μg/mL范围内与峰面积积分值线性关系良好(r=0.999 9,n=5),平均加样回收率为99.8%(RSD=0.45%)。结论:本方法测定结果准确、操作简便、灵敏度高、重复性好,可用于本品的质量控制。
Objective: To establish a HPLC method for the determination of phenylethylamine ethylamine injection. Methods: Amino-bonded silica column (5μm, 4.6mm × 250mm) was used as the mobile phase. The mobile phase consisted of methanol-0.2% potassium dihydrogen phosphate solution (10:90), the flow rate was 1.0mL / min, the detection wavelength was 223nm, The temperature is 25 ° C. Results: The calibration curve was linear (r = 0.999 9, n = 5) with an average recovery of 99.8% (RSD = 0.45%) in the range of 50.1 ~ 801.6 μg / mL. Conclusion: The method has the advantages of accurate determination, simple operation, high sensitivity and good repeatability. It can be used for the quality control of this product.