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(250mm×4.6mm,5μm),以55mmol·L-1磷酸二氢铵为流动相,流速为1mL·min-1,柱温30℃,进样体积为10μL,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24.14µg·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 x 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.
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