Development and validation of a rapid reversed-phase HPLC method for the quantification of monoclonal antibody bevacizumab from polyester-based nanoparticles
| Autor: | Flávia Sousa, Bruno Sarmento, Virgínia M.F. Gonçalves |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Bevacizumab
medicine.drug_class Calibration curve Clinical Biochemistry Pharmaceutical Science Nanoparticle 02 engineering and technology Monoclonal antibody 01 natural sciences Fluorescence spectroscopy Analytical Chemistry chemistry.chemical_compound Polylactic Acid-Polyglycolic Acid Copolymer Drug Discovery medicine Humans Lactic Acid Spectroscopy Chromatography High Pressure Liquid Chromatography Chemistry 010401 analytical chemistry Reproducibility of Results Reversed-phase chromatography 021001 nanoscience & nanotechnology 0104 chemical sciences Polyester PLGA Nanoparticles 0210 nano-technology Polyglycolic Acid medicine.drug |
| Zdroj: | Journal of pharmaceutical and biomedical analysis. 142 |
| ISSN: | 1873-264X |
| Popis: | Bevacizumab is a powerful human monoclonal antibody approved worldwide for treatment of several types of cancer and ocular diseases due to its potential as antiangiogenic drug. Nowadays, in order to improve the monoclonal antibody-based therapy, attempts have been focused in the formulation of these biomacromolecules into nanoparticles. Thus, the aim of this work was to develop and validate a reversed-phase high-performance liquid chromatography with fluorescence detection method for the determination of bevacizumab from nanoparticulate systems, according to the International Conference on Harmonization guidelines. Chromatographic analysis were performed on a RP-C8 column with a mobile phase composed by water-0.1% (v/v) TFA and acetonitrile-0.1% (v/v) TFA in gradient mode at a flow rate of 1mLmin-1. Results showed that the proposed method is specific, linear in the range of 10-100μgmL-1 (r2=0.9997), accurate (recovery rate 100.50±0.85%), precise at the intraday and inter-day (relative standard deviation less than 1.79%) and robust. The detection and quantification limits were calculated by specific linear calibration curve with less concentrated standard (range of 1-20μgmL-1). The LOD was 2.16μgmL-1 and LOQ was 6.55μgmL-1. This method was also successfully used, for the first time, to quantify and compare the content of bevacizumab encapsulated into poly(lactic-co-glycolic acid)-based nanoparticles before and after lyophilization. |
| Databáze: | OpenAIRE |
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