Determination of succinimide residual in PEG-EPO by HPLC
PANG Jia-pei
PANG Jian-yong
XU Guo-li
XIE Fu-sheng
Abstract：Objective To establish a method for the determination of residual succinimide in PEG - EPO by HPLC. Methods HPLC method was used and the separation was performed on a column packed with Shiseido Capcell PAK C18 AQ(4. 6 mm × 250 mm,5 μm). The mobile phase was 0. 02 mol·L-1 KH2 PO4( pH 6. 5). The detective wave-length was set at 210 nm. The flow rate was 0. 7 mL·min-1 . Results The linear range was good in 0. 08~0. 8 μg( r=1 ). The RSD of peak area of six repeated sampling was 0. 61%. The average recovery was 100. 96%. Conclusion The es-tablished method was simple,high sensitive and accurate with a high reproducibility and can be used for the determination of residual succinimide in PEG-EPO.
Keywords：Pegylated recombinant human erythropoietin( PEG-EPO)SuccinimideHPLC
Publication Date：2014-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 686-688 )