A Critical Review on Bioanalytical Methods Impurity Profiling, Degradation Study of Empagliflozin and Linagliptin

The development of sound Analytical method(s) is of supreme importance during the process of drug discovery, release to market and development, culminating in marketing approval. The objective of this paper is to review the method development, Impurity profile study, Degradation studies of the method for the drug production i.e Empagliflozin (EMP) and Linagliptin (LIN) from the developmental stage of the formulation to commercial batch of the product. Bioanalysis plays a vital role in drug discovery and development for the analysis of analytes (drugs, metabolites) in biological samples. To achieve a stable, reliable, and robust method one has to remove the interfaces from the sample matrix to improve bioanalytical system performance. This review provides an overview of the Impurity profile, Degradation study and various Analytical/Bio-Analytical method development of selected Anti-Diabetic drugs i.e EMP and LIN in single dosage form and their combination and a detailed investigation of different analytical techniques used for detection and quantification of these drugs on various matrices. Various techniques like spectroscopy, chromatography, electrochemical methods, and hyphenated techniques were reported to determine Anti-Diabetic drugs, either alone or in combination with other drugs, in different kinds of matrices like in bulk, existing dosage forms and also biological samples like plasma, serum, urine and myocardial tissue. Among various techniques used, HPLC, LC-MS systems are more commonly used because of their high sensitivity. This article summarizes the research works carried out since 2015 and intends to act as a handbook for future researchers.