Development of a Sustainable High-Performance Liquid Chromatography (HPLC) Method for Quantifying Metformin, Sitagliptin, and Empagliflozin in Type 2 Diabetes Treatment
Abstract
Objective: To develop and validate a green, environmentally sustainable high-performance liquid chromatography (HPLC) method for the simultaneous determination of three commonly used antidiabetic agents: Metformin Hydrochloride (MET), Sitagliptin Phosphate (STG), and Empagliflozin (EMP).
Study Design: Experimental analytical study.
Place and Duration of Study: This study was conducted at the State Company for Drugs Industry and Medical Appliances Samarra (SDI) Iraq from April 2024 to May 2024.
Methods: The chromatographic separation was achieved using an isocratic elution on a C10 column (4.6 × 250 mm, 5 µm) with a mobile phase consisting of phosphate buffer (20 mM), methanol, and acetonitrile in the ratio of 65:30:5 (v/v/v), adjusted to pH 2.9. The flow rate was maintained at 1.0 mL/min, with a column temperature of 30°C and a total run time of 15 minutes. Detection was performed using UV spectroscopy at 208 nm. Linearity was established for MET (0.08–0.13 mg/mL), STG (0.035–0.065 mg/mL), and EMP (0.014–0.026 mg/mL), with correlation coefficients exceeding 0.998 and RSD% not exceeding 1.06%. The method’s greenness was evaluated using AGREE and GAPI tools. Additionally, the Blue Applicability Grade Index (BAGI) was employed to assess operational and environmental suitability.
Results: The method exhibited high accuracy, reproducibility, and compliance with green analytical chemistry standards. The AGREE and GAPI assessments confirmed the method's minimal environmental…
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