Green Analytical Method Development and QbD-Based Validation of a Stability-Indicating UV–Visible Spectrophotometric Method for Simultaneous Estimation of Metformin and Sitagliptin in Combined Dosage Forms: Degradation Kinetics and Analytical Performance Evaluation

Challapalli Ravi; K. Kiran Kumar; G. Krishnaveni

Green Analytical Method Development and QbD-Based Validation of a Stability-Indicating UV–Visible Spectrophotometric Method for Simultaneous Estimation of Metformin and Sitagliptin in Combined Dosage Forms: Degradation Kinetics and Analytical Performance Evaluation

Author(s)	Mr. Challapalli Ravi, K. Kiran Kumar, G. Krishnaveni
Country	India
Abstract	Abstract The combination of metformin and sitagliptin in fixed doses is commonly used in the treatment of type 2 diabetes mellitus as they complement each other in glycemic regulation. As the importance of sustainability in the pharmaceutical analysis increases, there is an urgent need to find more environmentally friendly methods of analysis that will reduce the utilization of dangerous solvents without degrading the quality of analysis. The current research intends to design and prove a green, stability-sensing UV-visible spectrophotometric technique of the concomitant determination of metformin and sitagliptin in combined dosage forms by using a Quality by Design (QbD) methodology. Design of Experiments (DoE) was used to develop the method in a systematic manner in order to optimize important parameters, wavelength and solvent composition. The method was confirmed according to ICH Q2(R2) parameters and evaluated such parameters as linearity, accuracy, precision, robustness, and specificity. To evaluate the stability indicating capacity of the method, as well as to learn about the nature of degradation, forced degradation experiments under acidic, basic, oxidative, thermal and photolytic conditions were conducted. The optimized approach exhibited a high level of linearity, reproducibility, and robustness at a point that the effect of degradation was resolved clearly. The results prove that the suggested procedure is not complex, inexpensive and does not pollute the environment and can be considered as an affordable method of routine quality control analysis providing a long-term alternative to standard chromatographic methods.
Keywords	Green Analytical Chemistry, Quality by Design (QbD), UV–Visible Spectrophotometry, Metformin, Sitagliptin, Stability-Indicating Method, Degradation Kinetics
Field	Chemistry > Pharmacy
Published In	Volume 8, Issue 5, September-October 2026
Published On	2026-10-01

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Green Analytical Method Development and QbD-Based Validation of a Stability-Indicating UV–Visible Spectrophotometric Method for Simultaneous Estimation of Metformin and Sitagliptin in Combined Dosage Forms: Degradation Kinetics and Analytical Performance Evaluation

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