Development and Validation of Stability Indicating HPTLC Methods for Estimation of Vildaglitpin and Pioglitazone with Greenness Assessment using AGREE And AES

For the treatment of Type 2 Diabetes Mellitus, pioglitazone and vildagliptin is used in the treatment of type 2 diabetes mellitus. Pioglitazone and Vildagliptin is a combination of two antidiabetic medications. Vildagliptin and pioglitazone estimation in synthetic mixture was accomplished by the development and validation of a precise and accurate HPTLC method. The procedure used methanol, toluene, ethyl acetate, and ammonia in a ratio of 3.0:4.5:2.5:0.5 (v/v/v/v) as the mobile phase and HPTLC aluminum plates pre-coated with silica gel 60 F254 as the stationary phase used. Vildagliptin and pioglitazone were determined to have Rf values of 0.47 and 0.21 correspondingly. At 215 nm, densitometric analysis was performed in the absorbance mode. For pioglitazone and vildagliptin 250–1500 ng/band and 75-450 ng/band were the linear ranges in which the procedure produced results. Forced degradation studies were performed on both vildagliptin and pioglitazone active pharmaceutical ingredients like acid hydrolysis, base hydrolysis, chemical oxidation, dryheat and photodegradation studies. Vildagliptin and pioglitazone are susceptible to acid hydrolysis, base hydrolysis, chemical oxidation while both the chemical substances are stable to dry heat and photolytic studies. The greenness evaluation was carried out using AGREE, and analytical Eco-Scale assessment. Both tools indicated favorable environmental performance, reflecting low solvent toxicity, reduced analytical waste, and a balanced integration of efficiency with sustainability principles. The developed method passes all the ICH criteria; hence, the developed method is accurate, easy, suitable, and stable for the analysis of pioglitazone and vildagliptin in combined dosage form.