Bioanalytical Method Development and Validation for Empagliflozin and Semaglutide: A Comparative Review

Abstract

This review is a collection and thorough consideration of bioanalytical method development and validation of two revolutionary antidiabetic drugs Empagliflozin and Semaglutide. The quantitation of these agents in biological samples is important to support clinical and nonclinical studies, as they are therapeutic drugs for type 2 diabetes mellitus (T2DM) with increasing cardiovascular and renal uses. The two primary bioanalytical platforms mentioned are liquid chromatography Tandem Mass Spectrometry (LCMS) and Ultra Performance Liquid Chromatography Tandem Mass Spectrometry (UPLCMS/MS), which is considered the gold standard for bioanalysis. The report indicates differing principles required for drug analysis, a result of difference in chemical size, which Empagliflozin, a small molecule sodium-glucose cotransporter 2 (SGLT-2) inhibitor, can be quantified directly by routine LC-MS/MS methodology, versus Semaglutide, being a large peptide-based glucagon-like peptide-1 (GLP-1) receptor agonist, requiring significant sample preparation and custom hardware to mitigate problems such as poor ionisation efficiency and carryover. Validation of both drugs was performed according to the international guidelines particularly ICH M10 and found the developed method to possess excellent linearity, accuracy, precision and stability. This comprehensive evaluation indicates that the validated methods are reliable and sensitive for a routine, biomonitoring, and pharmacokinetic studies with data integrity which can be used for a worldwide registration.