A pilot study on potency determination of human follicle-stimulating hormone: A comparison between reversed-phase high-performance liquid chromatography method and the in vivo bioassay

A pilot study on potency determination of human follicle-stimulating hormone: A comparison between reversed-phase high-performance liquid chromatography method and the in vivo bioassay

Reversed-phase high-performance liquid chromatography (RP-HPLC) was compared with the classical Steelman–Pohley bioassay (BA), based on animal use, for the determination of human follicle-stimulating hormone (hFSH) biological activity. A linear relationship (BAIU=0.9925 RP-HPLCIU−1.3165) with a high...

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Veröffentlicht in:Journal of pharmaceutical and biomedical analysis 2011-03, Vol.54 (4), p.681-686
Hauptverfasser: Almeida, B.E., Oliveira, J.E., Damiani, R., Dalmora, S.L., Bartolini, P., Ribela, M.T.C.P.
Format: Artikel
Sprache:eng
Schlagworte:
Algorithms
Analysis
Analytical, structural and metabolic biochemistry
Animal Testing Alternatives
Animals
bioactive properties
Bioassay
bioassays
Biological and medical sciences
Biological Assay
Chemistry, Pharmaceutical
Chromatography, High Pressure Liquid
confidence interval
equations
Female
Follicle Stimulating Hormone, Human - analysis
Follicle Stimulating Hormone, Human - pharmacology
follicle-stimulating hormone
Fundamental and applied biological sciences. Psychology
General pharmacology
hFSH
Human follicle-stimulating hormone
human serum albumin
Humans
Medical sciences
Organ Size - drug effects
Ovary - drug effects
Ovary - growth & development
Pharmacology. Drug treatments
Pilot Projects
Potency
Quality Control
Rats
Rats, Sprague-Dawley
Recombinant Proteins - analysis
Recombinant Proteins - pharmacology
Reproducibility of Results
reversed-phase high performance liquid chromatography
RP-HPLC
Serum Albumin
Technology, Pharmaceutical
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Zusammenfassung:Reversed-phase high-performance liquid chromatography (RP-HPLC) was compared with the classical Steelman–Pohley bioassay (BA), based on animal use, for the determination of human follicle-stimulating hormone (hFSH) biological activity. A linear relationship (BAIU=0.9925 RP-HPLCIU−1.3165) with a highly significant correlation (r=0.9371; p
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2010.10.018