Optimized HPLC Method for Concurrent Quantification of Six Key Antidiabetic Agents in Pharmaceutical Analysis

Abstract

Diabetes mellitus represents a set of metabolism diseases that share chronic symptoms resulting from decreased insulin synthesis or insulin insensitivity causing increased blood glucose levels. This dysregulation in glucose metabolism underpins the multifaceted clinical manifestations and long-term complications associated with DM, necessitating vigilant management strategies to mitigate its adverse effects on health and well- being. The present study sought to create and verify a unique, reliable, fast, and accurate High-Performance Liquid Chromatography (HPLC) method for the quantitative examination of six antidiabetic drugs in tablet and bulk form, including metformin, sitagliptin, vildagliptin, linagliptin, empagliflozin, and dapagliflozin. A Dionex UltiMateTM3000 (Thermo Scientific) UHPLC chromatographic system using a column oven, a diode array detector, and an auto sampler was employed for this purpose. A straightforward, exact, selective, and specific HPLC method was successfully developed and validated. The present study's results showed markedly enhanced sensitivity, selectivity, and specificity as well as distinct and sharp peaks, indicating that the methodologies followed International Council for Harmonization (ICH) guidelines. The developed HPLC method has several benefits, such as complete separation of the six antidiabetic drugs in a shorter analysis run time. This efficiency not only lowers the total analysis time but also mitigates the period needed for reverse-phase HPLC column conditioned and mobile phase changes, which increases laboratory throughput. The testing of commercially available tablet dosage forms can be performed using the validated method, which has been shown to be highly accurate. It can also be used to analyse bulk dosages of metformin, sitagliptin, vildagliptin, linagliptin, empagliflozin, and dapagliflozin, either individually or concurrently. This versatility renders the methodology strongly versatile and applicable in various contexts, such as quality control, pharmacokinetic studies, and routine laboratory analysis. The method's broad utility in pharmaceutical research and industry applications is ensured by its capability to precisely and properly measure these drugs in both bulk and dosage form.