门冬胰岛素30注射液中硫酸鱼精蛋白的含量测定

The Determination of Protamine Sulfate in Aspart Insulin 30 Injection

目的:建立门冬胰岛素30注射液中硫酸鱼精蛋白含量的测定方法。方法:采用Hypersil GOLD C_(18)色谱柱(250 mm×4.6 mm,5μm);以0.1 mol/L磷酸二氢钠缓冲液(pH值为1.8)为流动相A,以0.1 mol/L磷酸二氢钠缓冲液-乙腈(65∶35)为流动相B;柱温55℃;流速1.0 mL/min;检测波长214 nm;进样量100μL。结果:该方法专属性好,在0.224~0.416 mg/mL浓度范围内,线性关系良好,稳定性、重复性与回收率良好。结论:此法可快速、简便、准确地测定门冬胰岛素30注射液中硫酸鱼精蛋白的含量。

Objective:To establish a method for the determination of protamine sulfate in aspart insulin 30 injection.Methods:Hypersil GOLD C_(18)column(250 mm×4.6 mm,5μm)was used.The mobile phase A was 0.1 mol/L sodium dihydrogen phosphate solution(pH 1.8),the mobile phase B was 0.1 mol/L sodium dihydrogen phosphate solution-acetonitrile(65∶35),and the column temperature was 55℃.The flow rate was 1.0 mL/min.The detection wavelength was 214 nm,and the injection volume was 100μL.Result:The method has good specificity.Within the concentration range of 0.224~0.416 mg/mL the linear relationship was good.The injection precision,stability,repeatability and recovery were good.This rapid,accurate method with high sensitivity provided a good choice for determination of protamine sulfate.