Abstract

FORCED DEGRADATION AND STABILITY INDICATING STUDIES OF IMATINIB TABLET

Farzana Hasin*, Md. Abdur Rouf Al Mamun, Md. Ershad Alam, Md. Ataur Rahman and Tanbir Ahmed

Abstract

Forced degradation or accelerated degradation is a process where drug products are of subjected to excessive chemical and environmental conditions. This study is usually used to identify the possible chemical reactions and responsible degradants (impurities) which are causing to degrade a drug product and usually conducted before final formulation; forced degradation uses external stresses to rapidly screen material stabilities. It is essential to validate specificity of stability demonstrating methods and also delivers a perception into degradation pathways and responsible degradants present in the drug material and supports in elucidation of the structure of the degradant. Long term storage tests are typically involved to measure alike properties whilst the ultimate drug formulations are engaged as of the strict FDA regulations. These tests are normally more costly (due to of the time required) than forced or accelerated degradation which is consequently used for rapid identification and elimination tests. Forced degradation experiments define the chemical nature of the degradant molecule which in turn assists in the improvement of the final formulation and package. This study discusses the existing trends of drug degradation studies by presenting an approach of performing further in-depth studies on drug degradation mechanisms and also shows the supportive workable analytical support for the development of stability representing method.

Keywords: Imatinib; Forced Degradation; HPLC.