论文部分内容阅读
目的:采用反相高效液相色谱法测定注射用右丙亚胺的含量。方法:采用Shim-pack CLC-ODS色谱柱(150mm×4.6mm,5μm),流动相为0.01mol·L-1磷酸二氢钾溶液-甲醇(85∶15),流速为1.0mL·min-1,检测波长为208nm,柱温为室温。结果:右丙亚胺进样浓度在4.04～40.36μg·mL-1范围内与峰面积呈良好的线性关系(r=0.9999),平均回收率(n=9)为99.7%,RSD为0.50%。结论:本方法操作简便,精密度好,结果准确可靠,可用于该制剂的质量控制。
Objective: To determine the content of dexrazoxane in injection by reversed-phase high performance liquid chromatography. Methods: Shim-pack CLC-ODS column (150mm × 4.6mm, 5μm) was used. The mobile phase consisted of 0.01mol·L-1 potassium dihydrogen phosphate solution and methanol (85:15) at a flow rate of 1.0mL · min -1 , The detection wavelength is 208nm, the column temperature is room temperature. Results: The concentration of dexrazoxane in the range of 4.04-40.36μg · mL-1 showed a good linear relationship with the peak area (r = 0.9999), the average recovery was 99.7% (n = 9) and the RSD was 0.50% . Conclusion: The method is simple, accurate, accurate and reliable, and can be used for the quality control of the preparation.