Harmonized Approach of Design of Experiments with Green and White Analytical Chemistry in Unified Framework for Synchronous Chromatographic Assay of Diverse Combinations of Anti-diabetic Drugs in Pharmaceutical Dosage Forms.

Abstract

Antidiabetic drugs, including metformin hydrochloride, are typically used to treat diabetes mellitus. Current methods for evaluating these drug combinations often involve the use of harmful solvents and specific conditions, leading to environmental risks and substantial toxic waste. White analytical chemistry proposes an innovative solution to this problem by developing environmentally friendly, cost-effective and user-friendly chromatographic methods. A synchronous chromatographic assay method for multiple combined pharmaceutical dosage forms of antidiabetic drugs was developed using a single set of chromatographic conditions and safe organic solvents. Method development was carefully carried out using a design of experiments approach to reduce organic solvent waste. The Plackett-Burman design was used in the screening phase to identify critical method variables and responses, facilitated by Minitab 18 software. The Box-Behnken design was then used to optimize these critical variables. A synchronous chromatographic assay of multiple combined pharmaceutical dosage forms was conducted under optimized chromatographic conditions. Finally, a thorough evaluation of the proposed and existing chromatographic methods was conducted using green and white analytical chemical metrics.