Determination of pegfilgrastim aggregates by size-exclusion high-performance liquid chromatography on a methacrylate-based column.

@article{Shahbazi2017DeterminationOP,
  title={Determination of pegfilgrastim aggregates by size-exclusion high-performance liquid chromatography on a methacrylate-based column.},
  author={Majid Shahbazi and Elnaz Tamaskany Zahedy and Shiva Kiumarsi and Mojtaba Hadi Soltanabad and Saleh Shahbazi Azar and Hossein Amini},
  journal={Biologicals : journal of the International Association of Biological Standardization},
  year={2017},
  volume={46},
  pages={
          153-158
        }
}
A size-exclusion high-performance liquid chromatographic method using a methacrylate-based column was developed, validated and implemented for the determination of pegfilgrastim aggregates. The samples were directly injected into a TSKgel G4000PWXL column (7.5 mm × 300 mm, 10 μm, <500 A°) with a mobile phase of 100 mM phosphate, pH 2.5. Detection was made at 215 nm and analyses were run at a flow-rate of 0.6 ml/min at 10 °C. Vortex-mixing of samples produced oligomers, however, very high… CONTINUE READING