| Full text | |
| Author(s): |
Almeida, B. E.
[1]
;
Damiani, R.
[1]
;
Oliveira, J. E.
[1]
;
Dalmora, S. L.
[2]
;
Torjesen, P. A.
[3]
;
Bartolini, P.
[1]
;
Ribela, M. T. C. P.
[1]
Total Authors: 7
|
| Affiliation: | [1] Cidade Univ, IPEN CNEN, Dept Biotechnol, BR-05508900 Sao Paulo - Brazil
[2] Univ Fed Santa Maria, Dept Ind Pharm, BR-97119900 Santa Maria, RS - Brazil
[3] Oslo Univ Hosp, Hormone Lab, N-0424 Oslo - Norway
Total Affiliations: 3
|
| Document type: | Journal article |
| Source: | ANALYTICAL METHODS; v. 6, n. 17, p. 6688-6694, SEP 7 2014. |
| Web of Science Citations: | 8 |
| Abstract | |
Reversed-phase high performance liquid chromatography (RP-H PLC) was compared to the in vivo bioassay (BA) based on TSH-induced T-4 determination in mice. A linear relationship (BA(mu g) = 0.9790 RP-HPLC mu g - 0.052) with a highly significant correlation (r = 0.87; p < 0.001; n = 14 preparations) was found between these two methods. The mean difference between the bioactivity predicted from RP-H PLC data via this equation and the mean of the bioactivities obtained with the two methods for 11 other hTSH preparations was -2.01%, with a 95% confidence interval of -13.13% to +9.11%. This analysis included 5 totally or partially-degraded samples, indicating a useful correlation between the two determinations and, as expected, a higher sensitivity of the physical-chemical method. Interestingly, a commercial hTSH tot did not show any alteration 2 years post expiration date. These results demonstrate that RP-H PLC is a novel and viable alternative to the use of in vivo bioassays for hTSH potency determination, thus avoiding or reducing animal use. (AU) | |
| FAPESP's process: | 11/07289-0 - Synthesis and characterization of different glycoforms of recombinant human thyrotropin (rhTSH) pharmacologically actives |
| Grantee: | Maria Teresa de Carvalho Pinto Ribela |
| Support Opportunities: | Regular Research Grants |