A Review on Impurity Profiling, Degradation Studies, and Bioanalytical Methods of Anti-diabetic Drugs

Abstract

According to ICH Q3A(R), the impurity in a new drug substance is “any component of a new drug substance that is not the chemical entity defined as a new drug substance”. As Per ICH Q3B(R), the impurity in a new drug product is “any component of the drug product that is not the drug substance and excipients in the drug product. “The forced degradation studies are used to facilitate the development of analytical methodology, to achieve a better understanding of the drug substance and the drug product stability, and to determine degradation pathways and the degradation products. This study will help to get the most stable formulation. The bioanalytical method development and validation is an essential part in the drug discovery and development. There is need to develop and validate bioanalytical methods, as sponsors have to submit clinical pharmacology, bioavailability, bioequivalence, pharmacokinetic evaluation along with non-human pharmacology and toxicology studies and preclinical studies to regulatory authorities. There are number of spectroscopic methods includes Ultraviolet spectroscopy, Mass spectroscopy, Nuclear magnetic resonance spectroscopy and Chromatographic methods includes HPLC,HPTLC,GC,UPLC as well as hyphenated techniques like LC-MS, LC/ESI-MS, LC-NMR-MS used for identification and characterization of impurities in an API and the drug products forced degradation study to obtain stability data and bioanalytical methods. The uniqueness of this review is that it describes the detail information and background explaining impurities, forced degradation and bioanalytical method development and validation as well as all literature available regarding development and validation of all said methods for the drugs and the drug products used to treat type 2 diabetes.