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

Autor(es)

Almeida, B. E. ^[1] ; Oliveira, J. E. ^[1] ; Damiani, R. ^[1] ; Dalmora, S. L. ^[2] ; Bartolini, P. ^[1] ; Ribela, M. T. C. P. ^[1]

Afiliação do(s) autor(es)

^[1] IPEN CNEN, Dept Biotechnol, BR-05508900 Sao Paulo - Brazil

^[2] Univ Fed Santa Maria, Dept Ind Pharm, BR-97119900 Santa Maria, RS - Brazil

• Tipo de documento: Artigo Científico
• Fonte: Journal of Pharmaceutical and Biomedical Analysis; v. 54, n. 4, p. 681-686, MAR 25 2011.
• Citações Web of Science: 8

Resumo

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 (BA(IU) = 0.9925 RP-HPLC(IU) - 1.3165) with a highly significant correlation (r=0.9371; p<0.0001; n = 24) was found for these two methods for six hFSH preparations of different origins. The mean difference between the bioactivity predicted from RP-HPLC data via this equation and the mean of the bioactivities obtained with the two methods for six other hFSH preparations was -1.4%, with a 95% confidence interval of -9.3 to +6.6%. The precision of these parameters was 1.63% and 2.82%, respectively. These results demonstrate that RP-HPLC is a viable physical-chemical alternative to the use of an in vivo bioassay for hFSH potency determination, applicable also to hFSH Standards containing large amounts of human serum albumin. (C) 2010 Elsevier B.V. All rights reserved. (AU)

• Processo FAPESP: 07/56094-2 - Sintese de tireotrofina humana (r-htsh) em celulas cho "humanizadas", capazes de introduzir a ligacao alfa-2,6 entre o acido sialico e a galactose.
• Beneficiário: Maria Teresa de Carvalho Pinto Ribela
• Modalidade de apoio: Auxílio à Pesquisa - Regular