Miniaturized green capillary electrophoresis system for the simultaneous analysis of Linagliptin and cefiximein in plasma

[Display omitted] •A miniaturized CE-PDA system was developed for Linagliptin (LIN) and Cefixime (CEF).•The system was designed and validated for the simultaneous analysis of LIN and CEF in plasma.•The system meets the criteria for US FDA for bioanalytical systems.•The validated system was successfully applied to analysis of real rat plasma samples.•The miniaturized and eco-friendly features of the CE-PDA system was proved. A novel combination therapy, consisting of the antidiabetic drug linagliptin (LIN) and the third-generation cephalosporin antibiotic cefixime (CEF), has recently been introduced to combat infections in diabetic patients. However, there is no published method for their in-vivo simultaneous determination in clinical biological specimens to support their pharmacokinetics and therapeutic monitoring. This study focuses on the development of a miniaturized capillary electrophoresis system-assisted with photodiode array detection (CE-PDA) for the simultaneous determination of LIN and CEF in clinical settings for analysis of plasma samples containing LIN and CEF. The conditions of electrophoretic separation of LIN, CEF, and Ibuprofen (as an internal standard), and the analysis procedures were successfully established. The linear range of the CE-PDA method was determined to be 0.5–100 µg mL−1 for LIN and 1–100 µg mL−1 for CEF. The CE-PDA approach exhibited high sensitivity, with limits of quantitation of 0.9 µg mL−1 for LIN and 1.2 µg mL−1 for CEF. In addition, the CE-PDA system was validated, and subsequently applied to real plasma samples withdrawn from rats received concurrent administration of LIN and CEF. The plasma protein was precipitated by acetonitrile. The miniaturized features of the system and its environmental impact were confirmed using three different metric tools. Additionally, the proposed CE-PDA system proved to be time-saving and cost-effective, making it highly suitable for therapeutic drug monitoring of LIN and CEF in clinical settings.