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目的:建立高效液相色谱(HPLC)法测定精蛋白锌胰岛素注射液中硫酸鱼精蛋白的含量。方法:采用Grace Vydac C18色谱柱(250 mm×4.6 mm,5μm),以A:乙腈-0.2 mol.L-1硫酸钠溶液(4∶96);B:乙腈-水(50∶50)为流动相进行梯度洗脱(0～8 min时B0%→70%,8～15 min时B70%,15～16 min时B70%→0%,16～30 min时B0%);流速1.0 mL.min-1;柱温40℃;检测波长:214 nm。结果:硫酸鱼精蛋白线性范围为0.05～2.5 mg.mL-1(r=0.9994),方法平均回收率(n=9)为99.7%。结论:本方法准确、简便、快速,重复性好,可用于精蛋白锌胰岛素注射液中硫酸鱼精蛋白的含量测定。
Objective: To establish a high performance liquid chromatography (HPLC) method for the determination of protamine sulfate in protamine sulfate protamine sulfate content. Methods: The column was run on a Grace Vydac C18 column (250 mm × 4.6 mm, 5 μm) using A: acetonitrile-0.2 mol.L-1 sodium sulfate solution (4:96); B: acetonitrile- water (B0% → 70% at 0-8 min, B70% at 8-15 min, B70% → 0% at 15-16 min, B0% at 16-30 min) at a flow rate of 1.0 mL · min -1; column temperature 40 ℃; detection wavelength: 214 nm. Results: The linear range of protamine sulfate was 0.05-2.5 mg.mL-1 (r = 0.9994). The average recoveries (n = 9) were 99.7%. Conclusion: The method is accurate, simple, rapid and reproducible. It can be used for the determination of protamine sulfate in protamine zinc insulin injection.