Stability Indicating Method for Simultaneously Estimation of Teneligliptin, Pioglitazone and Metformin Hydrochloride in Combined Tablet Dosage form by RP-HPLC

A reversed-phase HPLC method was designed and validated to serve as a stability-indicating technique for the simultaneous quantification of Teneligliptin, Pioglitazone, and Metformin Hydrochloride in a combined dosage form. This method utilized a Dionex system with a Force scientific C18 column (5μm, 250mm × 4.6mm i.d.) and employed a mobile phase consisting of phosphate buffer (pH 3), methanol, and acetonitrile in a 70:25:05 (%v/v) ratio, with UV detection set at 238nm. The method exhibited linearity across the concentration ranges of 12.5-75 μg/ml for Metformin, 0.5-3.0μg/ml for Teneligliptin, and 0.375-2.25μg/ml for Pioglitazone. It was assessed for system suitability, precision, accuracy, linearity, robustness, and forced degradation, demonstrating its effectiveness in separating the active pharmaceutical ingredients (APIs) from their degradation products and its applicability for analyzing samples of Teneligliptin, Pioglitazone, and Metformin.