HPLC法与UPLC法对比测定胰岛素类似物

目的用高效液相色谱(HPLC)法与超高效液相色谱(UPLC)法对比测定胰岛素类似物。方法 HPLC法采用Inertsil ODS-SP C18(4.6 mm×250 mm,5μm)色谱柱,以0.2 mol/L硫酸盐缓冲液(pH 2.3)-乙腈(82∶18)为流动相A,0.2 mol/L硫酸盐缓冲液(pH 2.3)-乙腈(50∶50)为流动相B,流速1.0 mL/min,梯度洗脱;检测波长214nm;柱温40℃。UPLC法采用Halo C18(4.6 mm×150 mm,2.7μm)色谱柱,以0.2 mol/L硫酸盐缓冲液(pH 2.3)-乙腈(82∶18)为流动相A,0.2 mol/L硫酸盐缓冲液(pH 2.3)-乙腈(50∶50)为流动相B,流速0.5 mL/min,梯度洗脱;检测波长214 nm;柱温40℃。结果 2种方法所得测定结果一致,精密度、回收率均符合要求。结论 UPLC较HPLC法更加简便迅速,UPLC法能够成功替代HPLC法,为胰岛素类似物及其制剂的质量控制提供新的检测方法。

Comparison of HPLC and UPLC for the determination of insulin analogs

Purpose To compare the methods-HPLC and ultra performance liquid chromatography(UPLC) for the determination of insulin analogs.MethodsA Inertsil ODS-SP C18(4.6 mm×250 mm,5 μm) was adopted with solution A and B as mobile phase at a flow rate of 1.0 mL/min,detective wavelength was set at 214 nm and column temperature was 40 ℃ in HPLC.A Halo C18(4.6 mm×150 mm,2.7 μm) was adopted with solution A and B as mobile phase at a flow rate of 0.5 mL/min,detective wavelength was set at 214 nm and column temperature was 40 ℃ in UPLC.ResultsBoth methods for this determination had the same results.ConclusionUPLC can not only increase separation speed and efficiency,but also reduce solvent consumption and analysis time.UPLC as a new detection method can replace HPLC for the quality control of insulin analogs and injections.