摘要
目的建立测定狂犬病人免疫球蛋白制品中甘氨酸含量的高效液相色谱法。方法采用Shim-Pack CLC-ODS色谱柱(150 mm×6.0 mm,5μm),以50%乙腈溶液-0.05 mol/L醋酸钠缓冲液(35∶65)为流动相,检测波长为360 nm。结果甘氨酸质量浓度在0.025～0.20 g/L范围内与峰面积呈良好线性关系(r=0.999 9),平均回收率为99.58%,RSD为1.18%(n=6)。结论所用方法简便灵敏,结果准确可靠,可用于狂犬病人免疫球蛋白制品中甘氨酸含量的测定。
Objective An HPLC method was established for the determination of glicine in human Rabies Immunoglobulin.Methods A Shim-Pack CLC-ODS column was used with the mobile phase of 50%acetonitrile-0.05 mol/L sodium acetate buffer（35 ∶65）,at the detection wavelength of 360 nm.Results The calibration curve of glicine was linear in the concentration range of 0.025～0.20 g/L.the average recovery was 99.58%,with RSD of 1.18%.Conclusion The method was simple and sensitive,and the determination result was accurate and reliable,indicating that the method was suitable for determination of glicine in human Rabies Immunoglobulin.
出处
《中国药业》
CAS
2012年第13期22-23,共2页
China Pharmaceuticals
