Box–Behnken Design-Based Optimized Kinetic Approach to Develop an Eco-friendly Analytical Method for the Quantitation of Glimepiride Using Spectrophotometry

Abstract

Purpose

The prevalence of type 2 diabetes mellitus is one of the global concerns and almost 80% of diabetic patients are treated with oral antidiabetic drugs. GLMP as a prescribed oral antidiabetic drug for diabetic patients enhanced its necessity. Therefore, it is essential to quantify it in several drug formulations and biological samples. Hence, a simple, eco-friendly, validated kinetic spectrophotometric method was developed for quantifying GLMP in commercial dosage forms.

Methods

The method was based on the oxidation of the GLMP with potassium permanganate. The reaction was followed spectrophotometrically, measuring an increase in absorbance with time at 605 nm. RSM optimized the influence of preliminary experimental variables for the proposed procedure via BBD, a frequently used DoE. Under the optimized conditions, initial rate, fixed-time (at 6.0 min), and equilibrium method (25.0 min) were adopted for constructing the calibration graphs to determine the amount of GLMP. The robustness of the proposed method was performed, and the effect of selected analytical parameters was investigated with alternative conditions employing Youden and Steiner’s test.

Results

The outcomes of the model were significant. Hence, the performance of the analytical method was validated statistically and through recovery studies using ICH guidelines. Calibration curves were linear in the concentration ranges of 4.0–36.0 µg/ml with a detection limit of 1.60, 1.02, and 1.13 µg/ml for the initial rate, fixed-time, and equilibrium method, respectively. The proposed method’s greenness profile was assessed using the analytical Eco-Scale and found greener in terms of using harmful reagents, energy consumption, and waste production. Statistical comparison of the results is shown in good agreement with the results found by the reference method, indicating no significant difference in accuracy and precision.

Conclusion

The proposed validated kinetic method is simple, accurate, low cost, safe, and eco-friendly and might be used in research laboratories, hospitals, and pharmaceutical industries for the routine quality control analysis of GLMP in commercial dosage forms.