反相离子对色谱法测定硫普罗宁注射液中乙二胺四醋酸盐的含量

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,5 μm);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30 μL。 结果: 依地酸钙钠浓度在0.89~53.83 μg·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1.82~91.22 μg·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 areversed-phase ion-pare HPLC method for the quantitative analysis of ethylenediamine tetraacetic acid salt in tiopronin injection. Methods: The chromatographic analysis were carried out on a Dikma Diamonsil C₈ Column(250 mm×4.6 mm,5 μm),and the mobile phase was methanol-40%tetrebutyl ammonium hydroxide-88%formic acid and water(125∶ 3.3∶ 0.6∶ 875).The detection was carried out at 254 nm,with a flow rate of 1.5 mL·min^-1.The column temperature was 40 ℃and injection volume was 30 μL. Results: Calcium disodium EDTA curves were linear in the range of 0.89-53.83 μg·mL^-1 (r=0.9998),the average recovery was 101.3%.Disodium EDTA curves were linear in the range of 1.82-91.22 μg·mL^-1 (r=1.0000),the average recovery was 99.0%. Conclusion: This rapid and simple method shows high specificity and reproducibility,which is suitable for the assay of EDTA-Calcium disodium and EDTA-Disodium in tiopronin injection.The results are accurate and reliable.