Determination of force degradation and solution stability studies of (bortezomib) proteasome inhibitor by HPLC method
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2015, Vol 3, Issue 5
Abstract
A forced degradation study is an essential step in the design of a regulatory compliant stability program for both drug substances and products, and formalized as a regulatory requirement in ICH Guideline Q1A in 1993. In designing forced degradation studies of Bortezomib, remembered that more strenuous conditions than those used for accelerated studies (25°C/60% RH or 40°C/75% RH) are used. Investigation was performed in conditions acid like base hydrolysis, hydrolysis at various pH, thermal degradation, photolysis, and oxidation. Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. Solution stability showing that more than 98 % of the Bortezomib remained unchanged after storage at room temperature for 12 h, on the basis of comparison of peak areas with those obtained from a freshly prepared solution of Bortezomib (200 ppm). This research paper showing solution stability and forced degradation studies of Bortezomib substances and Bortezomib products by providing a strategy for conducting studies on degradation mechanisms.
Authors and Affiliations
Suresh Kumar Agrawal, Dr. R. P Singh, Dr. Ritu M. Gilhotra, Dr. S. K Singh, Dr. Devendra Singh Rathore
Keywords
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- EP ID EP33333
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