Development and Validation of a Stability Indicating RP-HPLC Method for Simultaneous Estimation of Metformin, Tenegliptin, and Pioglitazone in bulk and its Pharmaceutical Dosage Form .

Abstract

A straightforward, reliable, and thorough approach was created for contemporaneously estimating Teneligliptin, Metformin, and Pioglitazone in solid dosage form. It was conducted by means of Agilent C18 150x4.6mm, 5µ. The mobile phase comprising buffer, acetonitrile, and Methanol (55:35:10 v/v) passed across the column at a pace of 0.9ml/min. The procedure relied on a 0.01N K2HPO4 buffer having a pH of 3.5, which was achieved by diluting an orthophosphoric acid solution. The temperature was kept constant at 30°C—optimized wavelength for Teneligliptin. Metformin and Pioglitazone were 220.0 nm. Retention times of Teneligliptin, Metformin, and Pioglitazone were 2.970 min, 2.395 min, and 3.642 min. %RSD of a system for Teneligliptin, Metformin, and Pioglitazone were 1.3, 0.6, and 1.0, respectively. %RSD of a method for Teneligliptin, Metformin, and Pioglitazone was 0.6 for each drug. The % recovery was 100.43, 100.45, and 100.22% for Teneligliptin, Metformin, and Pioglitazone, accordingly. The regression equations are used to generate the LoD and LoQ values of Teneligliptin, Metformin, and Pioglitazone, and LoD values were 0.016 ppm, 0.26 ppm, 0.42ppm, while LOQ values of Teneligliptin, Metformin and Pioglitazone were 0.048 ppm, 0.78 ppm,1.28 ppm respectively. The regression equation of Teneligliptin was y = 56655x + 920.87. Metformin was y = 14194x + 3082.1 and of Pioglitazone was y = = 41330x + 792.61.Reduced retention durations make the new approach easy and cost-effective for use in routine industrial quality control testing.