双氯芬酸二乙胺的有关物质测定

目的: 建立RP-HPLC法测定双氯芬酸二乙胺原料的有关物质。 方法: 采用Ultimate C₁₈色谱柱(250 mm×4.6 mm,5 μm),以甲醇-4%醋酸水溶液(65: 35)为流动相,流速为1 mL·min^-1,检测波长254 nm。 结果: 采用加校正因子的主成分自身稀释方法测定,方法的专属性强,双氯芬酸二乙胺浓度在1.011~20.22 μg·mL^-1范围内呈线性,线性方程为A=19.30C+0.3945,r=0.9999(n=5);最低检测限为0.50 ng。 结论: 本方法可用于双氯芬酸二乙胺有关物质的测定。

Objective: To establish a RP-HPLC method for the determination of related substances in diclofenac diethylamine. Methods: The test used an Ultimate C₁₈ column(250 mm×4.6 mm,5 μm). The mobile phase consisted of methanol-4% acetic acid solution(65: 35) at the flow rate of 1 mL·min^-1, the detection wavelength at 254 nm. Results: The main component self-compared with calibration factor was used to test the related substances. The method was specific. Diclofenac diethylamine had a good linear relationship in the range of 1.011-20.22 μg·mL^-1, the calibration curve was A=19.30C+0.3945, r=0.9999(n=5) and the lowest limit of detection was 0.5 ng. Conclusion: The method is simple,sensitive and rapid and it can be used for the determination of related substances in diclofenac diethylamine.

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