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

Shahbazi, M. and Tamaskany Zahedy, E. and Kiumarsi, S. and Hadi Soltanabad, M. and Shahbazi Azar, S. and Amini, H. (2017) Determination of pegfilgrastim aggregates by size-exclusion high-performance liquid chromatography on a methacrylate-based column. Biologicals, 46. pp. 153-158.

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Abstract

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 molecular weight aggregates were formed at high temperatures. The method exhibited linearity over the concentration range of 0.1–14 mg/ml for pegfilgrastim monomer and high molecular weight aggregates with a correlation coefficient of greater than 0.99. The method was specific and sensitive, with a lower quantification limit of 0.1 mg/ml and a detection limit of 0.02 mg/ml. Over 1200 samples were analyzed by the present method without significant change in the column performance. © 2017 International Alliance for Biological Standardization

Item Type: Article
Additional Information: cited By 0
Uncontrolled Keywords: granulocyte colony stimulating factor; methacrylic acid derivative; pegfilgrastim; recombinant protein, chemistry; devices; high performance liquid chromatography; molecular weight; procedures; reproducibility; size exclusion chromatography; temperature, Chromatography, Gel; Chromatography, High Pressure Liquid; Granulocyte Colony-Stimulating Factor; Methacrylates; Molecular Weight; Recombinant Proteins; Reproducibility of Results; Temperature
Subjects: مقالات نمایه شده محققین دانشگاه در سایت ,Web of Science ,Scopus
Divisions: UNSPECIFIED
Depositing User: GOUMS
Date Deposited: 18 Jun 2017 16:00
Last Modified: 18 Jun 2017 16:00
URI: http://eprints.goums.ac.ir/id/eprint/5085

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