A VALIDATED STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN, METFORMIN AND SAXAGLIPTIN IN BULK IN PHARMACEUTICAL ORAL DOSAGE FORMS.

Abstract

Metformin, Dapagliflozin, and Saxagliptin in solid dose form were estimated simultaneously using a simple, accurate, and exact approach. The chromatogram was conducted on an Agilent C18 150x4.6mm, 5mm. A mobile phase comprising acetonitrile and 0.01N Kh2Po4 in a 70:30 v/v ratio was injected through the column at a flow rate of 1.2mL/min. Buffer pH was adjusted to 3.5pH using Ortho Phosphoric Acid. The temperature was kept at 26 °C. The optimal wavelength for Metformin, Dapagliflozin, and Saxagliptin was 238.0 nm. Metformin, dapagliflozin, and saxagliptin had retention times of 3.598, 2.827, and 3.209 minutes, respectively. The %RSD of system accuracy for Metformin, Dapagliflozin, and Saxagliptin were determined to be 0.7, 0.4, and 0.6, respectively. The %RSD of method precision for Metformin, Dapagliflozin, and Saxagliptin were determined to be 0.7, 0.9, and 0.4, respectively. Metformin, Dapagliflozin, and Saxagliptin showed percentage recovery rates of 100.03%, 100.23%, and 99.64%, respectively. LOD values are derived using regression models for Metformin, Dapagliflozin, and Saxagliptin. The LOQ values for Metformin, Dapagliflozin, and Saxagliptin were 1.62 μg/ml, 0.12 μg/ml, and 0.05 μg/ml, respectively, based on regression models. The regression equation for Metformin was y = 5641.2x + 8389.3. Dapagliflozin was y = 6070.3x + 132, whereas Saxagliptin was y = 5843.6x + 75.1. Retention durations are reduced, therefore the method devised was easy and cost-effective, and it may be used in frequent quality control tests in industries.