Development and Validation of a Green Method for Simultaneous Determination of Alogliptin and Pioglitazone in Bulk, Combined Tablet Dosage Forms, and Spiked Human Plasma by High-Performance Thin-Layer Chromatography

A high-performance thin-layer chromatography (HPTLC) technique that indicates stability was created and verified. to simultaneously quantify the active pharmaceutical ingredients pioglitazone, alogliptin, and their fixed-dose combination. This method is characterized by its clarity, directness, precision, and accuracy.Methods: Densitograms of alogliptin (ALO) and pioglitazone (PIO) were created using n-butanol: water: glacial acetic acid: ammonia (8.0:0.5:0.5:1.0v/v) as the mobile phase and HPTLC plates (silica gel 60 F254) as the stationary phase. Densitometric quantification was implemented at a wavelength of 254 nm.Results: The values of RF for Alogliptin and Pioglitazone were determined to be 0.28 and 0.75, respectively. The method's robustness, specificity, accuracy, and precision were all verified. With correlation coefficients of 0.9998 and 0.9990 for Alogliptin and Pioglitazone, respectively, the linearity was obtained in the concentration range of 125.0-2000.0 ng/band for Alogliptin and 250.0-4000.0 ng/band for Pioglitazone. The lowest quantity that could be quantified by the suggested method was found to be 0.31 and 2.75 ng /band for ALO and PIO, respectively. The detection limit for Alogliptin and Pioglitazone was found to be 0.1 and 0.9 ng/band, respectively. The environmental impact of the method was assessed using various greenness evaluation tools, confirming its eco-friendly nature.Conclusion: After validation, the method was determined to be specific, selective, and appropriate for analyzing these medications, whether in bulk form or fixed-dose combinations.