Stability-Indicating TLC-Densitometric and HPLC Methods for Simultaneous Determination of Teneligliptin and Pioglitazone in Pharmaceutical Dosage Forms with Eco-Friendly Assessment

Abstract

The combination of multiple drugs in pharmaceutical formulations has greatly improved the management of complex medical conditions, particularly benefiting patients with type 2 diabetes mellitus. Two powerful antidiabetic agents, teneligliptin hydrobromide hydrate (TEN) and pioglitazone hydrochloride (PIO), play key roles in regulating blood glucose levels. In this study, we introduce innovative methods for the simultaneous quantification of TEN and PIO in pharmaceutical formulations, ensuring accuracy and stability assessment. Our TLC-densitometric approach employs a mobile phase consisting of Methanol, Toluene, Ethyl Acetate, and Triethylamine (1:7:2:0.1, v/v/v/v) on TLC silica gel plates, followed by densitometric scanning at 268 nm. Meanwhile, the RP-HPLC method utilizes an isocratic elution with acetonitrile and acetate buffer (pH 2.3, 60:40 v/v) on a C18 column, delivering diode-array detection at 235 nm. Both methods offer exceptional accuracy and reliability, serving as valuable tools for pharmaceutical quality control. Furthermore, our research incorporates an environmental impact assessment to align with global sustainability goals. We consider factors such as solvent consumption, waste generation, and energy usage, using assessment tools like the eco-scale assessment, AGREE, Green Analytical Procedure Index (GAPI), and the national environmental method index (NEMI) to gauge the environmental impact of our methods. By adopting these techniques, pharmaceutical companies can enhance their drug quality control processes and fulfill their environmental responsibilities. Comprehensive statistical comparisons, including t-tests and F-tests, validate the outcomes of the TLC-densitometric and RP-HPLC methods, ensuring their effectiveness in drug formulation analysis.