Acta Biomedica Scientia

GENOTOXICITY EVALUATION FOR THE STRESS INDUCED DEGRADANTS IN DIACEREIN

Jeyaprakash MR*, Avnendra Yadav, Ashish Devidas Wadhwani, Meyyanathan SN

jpvis7@gmail.com

Diacerein, Impurities, Genotoxicity, Forced degradation, Ames test.

Genotoxicity evaluation is an in vitro and in vivo test processes to decide the undesirable effects of chemical entity. It helps to evaluate the effect of chemical substance towards the induce genetic damage by various mechanisms. Regulatory authorities framed strict measures to control the genotoxic impurities in the active pharmaceutical ingredients. Monograph books have been already prescribed with certain related substances as an impurities raised from different level like last intermediates of synthesis, products of incomplete reactions, products of over reactions, impurities originating from starting materials, impurities originating from solvent materials, Impurities originating from catalysis. Product of side chain reactions, degradation products, enantiomeric excess, residual solvents, Inorganic impurities, and impurities in excipients. Active pharmaceutical ingredients undergo degradation with uncertain pathway hence the biosafety of those materials certainly could not be concluded in the initial stage. The present study aim to force the diacerein to different climatic condition to evaluate its different degrading pathway. The drug explored to different stress conditions, the stressed diacerein subjected to HPLC separation to isolate and separate the known and unknown impurities. The new impurities were isolated and structurally elucidated by evaluate their spectral data. Impurities were subjected to genotoxic effect using AMES test model. Based on the structural alert certain impurities were produced reverse mutation colony growth. The Ames model produced the revert colony formation in certain impurities. To conclude the bio-safety, the entire degradation product should be examined for their mutogenic character, all the impurities bio safety profile should be recorded by bulk drug manufacturers.