RP-HPLC测定注射用右丙亚胺的含量及有关物质___
RP-HPLC determination of dexrazoxane for injection
分类号：
出版年·卷·期（页码）：2009,29 (8):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
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(150 mm×4.6 mm，5 μm)，流动相为0.01 mol•L-1磷酸二氢钾溶液-甲醇(85∶15)，流速为1.0 mL·min-1，检测波长为208 nm，检温为室温。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。
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To establish an HPLC method for determining the content of dexrazoxane for injection.Methods:Shim-pack CLC-ODS column (250 mm×4.6 mm，5 μm)was used.The mobile phase was 0.01 mol·L-1 potassium dihydrogen phosphate solium-methanol（85∶15）.The flow rate was 1.0 mL•min-1.The detection wavelength was 208 nm.The temperature of the column was controlled at room temperature .Results: The calibration curve was linear in the range of 4.04～40.36 μg·mL-1 for dexrazoxane (r=0.9999). The average recovery(n=9) was 99.7%,and relative standard deviation was 0.50%.Conclusion: The method is simple, accurate and reliable,it can be used to control this preparation.
-----参考文献：---------------------------------------------------------------------------------------
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