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目的:建立硫普罗宁注射液中乙二胺四醋酸盐含量的反相离子对色谱测定方法。方法:采用Dikma Diamonsil C8柱(250 mm×4.6 mm,5μm);以甲醇-40%四丁基氢氧化铵-88%甲酸-水(125∶3.3∶0.6∶875)为流动相;流速1.5 mL·min-1;柱温40℃;检测波长254 nm;进样体积30μL。结果:依地酸钙钠浓度在0.89～53.83μg·mL-1范围内与峰面积呈良好的线性关系,r=0.9998,平均加样回收率为101.3%;乙二胺四醋酸二钠浓度在1.82～91.22μg·mL-1范围内与峰面积呈良好的线性关系,r=1.0000;平均加样回收率为99.0%。结论:该方法快速、简便,专属性强,重复性好,结果准确可靠,适用于硫普罗宁注射液中乙二胺四醋酸盐的含量测定。
Objective: To establish a reversed-phase ion pair chromatography method for the determination of ethylene diamine tetraacetate in tiopronin injection. Methods: A Dikma Diamonsil C8 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was methanol 40% tetrabutylammonium hydroxide -88% formic acid-water (125: 3.3: 0.6: 875) -1; column temperature 40 ℃; detection wavelength 254 nm; injection volume 30μL. Results: The concentration of sodium edetate in the range of 0.89 ~ 53.83 μg · mL-1 showed a good linear relationship with the peak area, r = 0.9998, the average recovery was 101.3%. The concentration of disodium ethylenediaminetetraacetate 1.82 ~ 91.22μg · mL-1 range and the peak area showed a good linear relationship, r = 1.0000; average recovery was 99.0%. Conclusion: The method is rapid, simple, specific, reproducible and accurate. It is suitable for the determination of ethylene diamine tetraacetate in tiopronin injection.