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Pregled bibliografske jedinice broj: 765667

Purity assessment of recombinant human granulocyte colony-stimulating factor in finished drug product by capillary zone electrophoresis


Benković, Goran; Škrlin, Ana; Madić, Tomislav; Debeljak, Željko; Medić-Šarić, Marica
Purity assessment of recombinant human granulocyte colony-stimulating factor in finished drug product by capillary zone electrophoresis // Electrophoresis, 35 (2014), 18; 2608-2614 doi:10.1002/elps.201300552 (međunarodna recenzija, članak, znanstveni)


Naslov
Purity assessment of recombinant human granulocyte colony-stimulating factor in finished drug product by capillary zone electrophoresis

Autori
Benković, Goran ; Škrlin, Ana ; Madić, Tomislav ; Debeljak, Željko ; Medić-Šarić, Marica

Izvornik
Electrophoresis (0173-0835) 35 (2014), 18; 2608-2614

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
Capillary zone electrophoresis; Filgrastim; Purity; Recombinant human granulocyte colony-stimulating factor; Validation

Sažetak
Current methods for determination of impurities with different charge-to-volume ratio are limited especially in terms of sensitivity and precision. The main goal of this research was to establish a quantitativemethod for determination of impuritieswith charges differing from that of recombinant human granulocyte colony- stimulating factor (rhG-CSF, filgrastim) with superior precision and sensitivity compared to existing methods. A CZE method has been developed, optimized, and validated for a purity assessment of filgrastim in liquid pharmaceutical formulations. Optimal separation of filgrastim from the related impurities with different charges was achieved on a 50 m id fused-silica capillary of a total length of 80.5 cm. A BGE that contains 100 mM phosphoric acid adjusted to pH 7.0 with triethanolamine was used. The applied voltage was 20 kV while the temperature was maintained at 25°C. UV detection was set to 200 nm. Method was validated in terms of selectivity/specificity, linearity, precision, LOD, LOQ, stability, and robustness. Linearity was observed in the concentration range of 6– 600 g/mL and the LOQ was determined to be 0.3% relative to the concentration of filgrastim of 0.6 mg/mL. Other validation parameters were also found to be acceptable ; thus the method was successfully applied for a quantitative purity assessment of filgrastim in a finished drug product.

Izvorni jezik
Engleski

Znanstvena područja
Kemija, Farmacija, Biotehnologija



POVEZANOST RADA


Ustanove
Farmaceutsko-biokemijski fakultet, Zagreb,
Pliva-Istraživački institut

Profili:

Avatar Url Ana Škrlin (autor)

Avatar Url Marica Medić-Šarić (autor)

Avatar Url Željko Debeljak (autor)

Citiraj ovu publikaciju

Benković, Goran; Škrlin, Ana; Madić, Tomislav; Debeljak, Željko; Medić-Šarić, Marica
Purity assessment of recombinant human granulocyte colony-stimulating factor in finished drug product by capillary zone electrophoresis // Electrophoresis, 35 (2014), 18; 2608-2614 doi:10.1002/elps.201300552 (međunarodna recenzija, članak, znanstveni)
Benković, G., Škrlin, A., Madić, T., Debeljak, Ž. & Medić-Šarić, M. (2014) Purity assessment of recombinant human granulocyte colony-stimulating factor in finished drug product by capillary zone electrophoresis. Electrophoresis, 35 (18), 2608-2614 doi:10.1002/elps.201300552.
@article{article, year = {2014}, pages = {2608-2614}, DOI = {10.1002/elps.201300552}, keywords = {Capillary zone electrophoresis, Filgrastim, Purity, Recombinant human granulocyte colony-stimulating factor, Validation}, journal = {Electrophoresis}, doi = {10.1002/elps.201300552}, volume = {35}, number = {18}, issn = {0173-0835}, title = {Purity assessment of recombinant human granulocyte colony-stimulating factor in finished drug product by capillary zone electrophoresis}, keyword = {Capillary zone electrophoresis, Filgrastim, Purity, Recombinant human granulocyte colony-stimulating factor, Validation} }

Časopis indeksira:


  • Current Contents Connect (CCC)
  • Web of Science Core Collection (WoSCC)
    • Science Citation Index Expanded (SCI-EXP)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE


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