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Abstract

Rosuvastatin is a widely used lipid-lowering medication that belongs to the class of "Statins" whereas Teneligiptin is a novel potent drug that belongs to the class of "DPP-4 inhibitors" which is used for the treatment of Type 2 Diabetes mellitus. The FDA recently approved the combination of these two drugs in 2021 since it proved to be highly effective for treating dyslipidemia associated with Type 2 Diabetes mellitus. Forced degradation studies have been performed on Rosuvastatin and Teneligliptin separately using various analytical techniques such as RP-HPLC, UV, RP-UFLC, RP-UPLC, UHPLC, HPTLC and TLC. Characterization of the degradation products generated during various stress conditions is also performed using various sophisticated techniques such as UPLC, LC/MS/MS, NMR, and FT-IR. These degradants can cause many adverse effects, such as carcinogenicity, mutagenicity, neurotoxicity, hepatotoxicity, skin sensitization, respiratory sensitization, etc. So, identifying and characterizing these degradation products will be very useful for their metabolic studies and in-silico toxicity assessment. In-silico toxicity studies are very helpful in predicting the toxic potential of these degradants, and it is performed using various software such as TOPKAT, Osiris, and DEREK. Thus, the present review aims to summarise the forced degradation studies as well as characterization of the degradation products generated from both rosuvastatin and teneligliptin using various modern analytical techniques so that it will significantly contribute in the future regarding their metabolic studies, determination of impurities during their bulk synthesis as well as toxicity predictions.INTRODUCTION: Degradation can be defined as the incapability of a particular substance to remain within its particular physical, chemical, microbiological, toxicological, and therapeutic specifications. "Forced degradation can be defined as the degradation of a New drug substance or new drug product at conditions more severe than the accelerated conditions.