Ertugliflozin Analysis: Chromatographic and Spectrophotometric Approaches

Ertugliflozin, being an SGLT2 inhibitor, is extensively applied in managing type 2 diabetes mellitus through enhancing glycemic control. With the pharmaceutical industries seeking compliance with regulatory requirements, the demand for accurate, dependable, and effective analytical methods for the determination and quality assessment of ertugliflozin has grown. In this article, the authors give an extensive overview of different analytical methodologies designed for determining ertugliflozin in pharmaceutical formulation, bulk samples, and in biological matrices. The major thrust is given to chromatographic methodology, especially to high-performance liquid chromatography (HPLC), which has been the best choice owing to its ruggedness, accuracy, and precision. We assess various detection methods used in conjunction with HPLC, such as UV and fluorescence, and development of reversed-phase HPLC (RP-HPLC) for enhanced resolution. We also discuss alternative methodologies like spectrophotometric and electrochemical methodologies, each possessing unique advantages for matrix and analysis needs. Important factors that go into method development, such as column type, detection wavelength, and mobile phase composition, are elaborated at length. In addition, critical validation parameters like linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ) are tested in accordance with the International Council for Harmonization (ICH) and other regulatory agency guidelines.