Validation of the Chromogenic Bioassay for the Potency Assessment of Streptokinase in Biopharmaceutical Formulations
- *Corresponding Author:
- Sérgio Luiz Dalmora
Department of Industrial Pharmacy
Federal University of Santa Maria Santa Maria, RS, Brazil
E-mail: [email protected]
Received date: September 30, 2015 Accepted date: October 14, 2015 Published date: October 21, 2015
Citation: Xavier B, Camponogara BL, Júnior CDAC, Perobelli RF, Walter ME, et al. (2015) Validation of the Chromogenic Bioassay for the Potency Assessment of Streptokinase in Biopharmaceutical Formulations. J Anal Bioanal Tech 6:287.doi:10.4172/2155-9872.1000287
Copyright: © 2015 Xavier B, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Streptokinase (STK) is a thrombolytic agent clinically used to treat patients with acute myocardial infarction and venous and arterial thrombosis. An in vitro chromogenic substrate end point bioassay was validated for the potency evaluation of biopharmaceutical formulations. The dose-response curve was linear over the concentration range of 2.50-40 IU/mL (r2=0.999), with a quantitation limit of 2.50 IU/mL and a detection limit of 1.10 IU/mL, respectively. Specificity was established in studies with spiked samples. The accuracy was 100.34% with bias lower than 0.53%, and method validation demonstrated also acceptable results for precision and robustness. The validated method was applied to the potency assessment giving potencies between 92.20% and 108.97%. In addition, the activity of streptodornase and streptolysin were also evaluated giving values lower than 9.79 IU per 100 000 IU STK, and 1.47 for the absorbance ratio, respectively. The validated bioassay was applied in combination with the purity evaluation, contributing to assure the batch-to-batch consistency and quality of the bulk and finished biotechnology-derived medicine.