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Simultaneous analysis of filgrastim and pegfilgrastim aggregates by size-exclusion chromatography

Tamaskany Zahedy, E. and Farzane Yegane, D. and Shahbazi, M. and Amini, H. (2020) Simultaneous analysis of filgrastim and pegfilgrastim aggregates by size-exclusion chromatography. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 1152.

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Abstract

A new size-exclusion high-performance liquid chromatographic (SE-HPLC) method for the simultaneous analysis of filgrastim and pegfilgrastim aggregates was developed and validated. A cross-linked agarose and dextran column was used at ambient temperature and an alkaline sodium phosphate buffer as mobile phase eliminated non-ideal interactions with the stationary phase. The robustness of the method was assessed by varying injection volumes, flow rates and sample vehicles. Other reliability assessments include calibration curve, intra and inter-day precision and accuracy, repeatability of retention times, application to real in-process production samples and column lifetime. The method exhibited linearity over the concentration of 0.02�4 mg/ml range for filgrastim and pegfilgrastim monomer with a correlation coefficient of greater than 0.999. The lower limit of quantification was 0.02 mg/ml and the limit of detection was 0.005 mg/ml. This SE-HPLC technique has been successfully used for several years and more than 10,000 samples. © 2020 Elsevier B.V.

Item Type: Article
Additional Information: cited By 0
Uncontrolled Keywords: Aggregates; High performance liquid chromatography; Sodium compounds, Calibration curves; Correlation coefficient; Limit of detection; Lower limit of quantifications; Reliability assessments; Simultaneous analysis; Sodium phosphate buffer; Stationary phase, Size exclusion chromatography, agarose; dextran; filgrastim; monomer; pegfilgrastim; sodium dihydrogen phosphate, Article; controlled study; environmental temperature; high performance liquid chromatography; limit of detection; limit of quantitation; measurement accuracy; measurement repeatability; priority journal; reliability; retention time; size exclusion chromatography
Subjects: سیستم های خونی و لنفاوی WH
QU بیوشیمی
آسیب شناسی QZ
آسیب شناسی بالینی QY
میکروب شناسی وایمنی شناسی QW
مقالات نمایه شده محققین دانشگاه در سایت ,Web of Science ,Scopus
Divisions: معاونت تحقیقات و فناوری
Depositing User: GOUMS
Date Deposited: 12 Jul 2020 09:22
Last Modified: 12 Jul 2020 09:22
URI: http://eprints.goums.ac.ir/id/eprint/10702

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