Environmentally Friendly HPLC Method for Two Antidiabetic Agents for Simultaneous Estimation

Eco-friendly analytical procedure refers to reducing or eliminating the hazardous solvents and reagents used during the analysis of APIs as well as pharmaceuticals by chromatographic technique. The antidiabetic agents sitagliptin phosphate monohydrate and metformin hydrochloride, which are mainly prescribed for the treatment of type 2 diabetes mellitus. The QbD-based method development strategies are rapid, robust, and environmentally sustainable. The instrument, high-performance liquid chromatography, was used during method development and optimised using Design-Expert software to identify critical method parameters with respect to the response of critical analytical attributes. The optimised method used chromatographic conditions with an ambient column oven temperature and a flow rate of 1.15 mL/min. The λ256 nm, the mobile phase 55:45 (v/v) of KH2PO4 and ethanol, the buffer pH 4.50, the column dimensions were 4.6 mm of internal diameter, 250 mm length, and the particle size of the stationary phase was 5 micrometres and 100 angstrom pore size. The optimised method was validated in accordance with the International Council of Harmonisation Q2R1. Therefore, the method is robust and eco-friendly and can quantify both APIs and branded formulations using high-performance liquid chromatography.