European Journal of Biomedical and Pharmaceutical Sciences

FORCED DEGRADATION AND STABILITY INDICATING STUDIES OF PHARMACEUTICAL DOSAGE FORM (ROSUVASTATIN TABLET)

*Md. Iftekhar Hussain, Farzana Hasin, Md. Mofazzal Hossain, Md. Mahabob Ullah Mazumder and Nayeema Afrin Habib

ABSTRACT

This forced degradation study of Rosuvastatin has been demonstrated an accurate approach to develop and establish the stability-indicating methods of this drug, that is reliable with all current pharmaceutical regulatory guidelines. Practical experiment based commendations are provided for developing the effective forced degradation protocols which must be followed at every stage of drug development to evade common hazards that may confuse data interpretation in every analytical procedure. This study will also afford essential information’s about the possible degradation pathways, responsible degradants and ultimately the degradation products which could have shaped during drug product storage. The available regulatory guidance provides useful definitions and general comments about degradation studies. This study illustrates the modern trends of forced degradation studies by providing a significant strategy to carryout studies on drug degradation mechanisms as well revealed the analytical methods of Rosuvastatin that is supportive for development of stability indicating method of this drug.

Keywords: Rosuvastatin; Forced Degradation; HPLC; Degradation Pathways; Degradation Products.