HPLC-RID法测定钆布醇注射液中的氨丁三醇含量

目的： 建立钆布醇注射液中氨丁三醇含量的高效液相色谱-示差折光检测器（HPLC-RID）的定量分析方法，并对该方法进行分析方法验证。方法：采用高效液相色谱法，资生堂CAPCELL PAK SCX色谱柱（250 mm×4.6 mm，5 μm），以55 mmol·L-1磷酸二氢铵为流动相，流速为1 mL·min-1，柱温30℃，进样体积为10 μL，示差折光检测器（RID）检测。结果：氨丁三醇在0.60 ~ 2.41mg· mL-1浓度范围内线性关系良好，相关系数（r）为0.999 9；定量限为24.14 μg· mL-1；平均回收率为101.3%，RSD为0.5%（n = 9）。结论：该方法专属性强，准确度高，可以作为钆布醇注射液中氨丁三醇的定量分析方法。

Determination of Tromethamine in Gadobutrol Injections by HPLC-RID

Objective: To establish and verify an high performance liquid chromatography with tandem differential refractive index detector (HPLC-RID) method for the detection of tromethamine in Gadobutrol injections. Methods: The samples were analyzed by HPLC using a Shiseido CAPCELL PAK SCX column (250 mm × 4.6 mm, 5 μm) with an RID detector. The mobile phase was 55 mmol·L-1 ammonium dihydrogen phosphate buffer solution and the flow rate was 1 mL·min-1. The column temperature was 30℃ and the injection volume was 10 μL． Results: The linear range of tromethamine was 0.60 - 2.41 mg·mL-1, and r was 0.999 9. The lower limit of quantification was 24.14 μg·mL-1. The average recovery of tromethamine was 101.3% with the RSD of 0.5% (n = 9). Conclusion: The established method has strong specificity, good precision and high accuracy, which can be used for determination of tromethamine in Gadobutrol injections.