Review on development of forced degradation studies and its approaches on stability indicating method

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Sheetal J. Rathod, Dr. Shailesh V. Luhar, Dr. Sachin B. Narkhede

Abstract: Forced degradation studies an essential tool in pharmaceutical research and development were degradation pathways and degradation product of the drug product and substance is important for understanding chemical behavior and for stable development of formulation. This review discuss about the forced degradation study as per the regulatory guidelines and other regulatory agencies. In Forced degradation studied there are certain degradation condition like oxidation, hydrolysis, photolysis etc. Forced degradation discuss various tools for investigation of degradants. It discuss about the prediction of drug product and provide information for degradation and its pathway for the development of stability indicating method. In this review also discuss about the various analytical techniques such as conventional and hyphenated techniques for gaining the detail about the degradants separation and its characteristic.


Key words: – forced degradation, degradation condition, stability indicating method.

forced degradation, degradation condition, stability indicating method.