Advanced search
Start date
Betweenand
Related content
(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

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

Full text
Author(s):
Almeida, B. E. [1] ; Oliveira, J. E. [1] ; Damiani, R. [1] ; Dalmora, S. L. [2] ; Bartolini, P. [1] ; Ribela, M. T. C. P. [1]
Total Authors: 6
Affiliation:
[1] IPEN CNEN, Dept Biotechnol, BR-05508900 Sao Paulo - Brazil
[2] Univ Fed Santa Maria, Dept Ind Pharm, BR-97119900 Santa Maria, RS - Brazil
Total Affiliations: 2
Document type: Journal article
Source: Journal of Pharmaceutical and Biomedical Analysis; v. 54, n. 4, p. 681-686, MAR 25 2011.
Web of Science Citations: 8
Abstract

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)