DEVELOPMENT AND VALIDATION OF QBD-ASSISTED RP-HPLC METHOD FOR DAPAGLIFLOZIN AND METFORMIN HCL IN BULK AND ITS COMBINED DOSAGE FORMAbstract
Dapagliflozin and Metformin HCl Combination is the novel SGLT2 inhibitor used to control Hyperglycemia in type 2 diabetes mellitus. A literature survey reveals that various Analytical methods have been developed for Dapagliflozin in single and combined with other drugs. No QbD-assisted RP-HPLC method is available to estimate Dapagliflozin and Metformin HCl in combination. So, present work describes the development and validation of QbD driven RP-HPLC method for Dapagliflozin and Metformin HCl. The RP HPLC method has been developed using Agilent 1200 series HPLC with Intersil ODS column (250 x 4,6mm, 5 µm). Based on the RP-HPLC method, development Flow rate and pH were selected as CAA and Resolution, Retention time and Tailing of Drug were monitored using Design Expert@13.00. By applying CCD, 9 trials, 2 factors and 3 responses method had been selected for method development for Dapagliflozin and Metformin HCl. The optimum method development was selected based on the criteria of attaining appropriate Resolution, Tailing, and retention time. The overlay plot of responses generates an optimized area as per desired criteria of Resolution 12.65, Tailing 1.09 and the retention time of 2.48 min using ACN: KH2PO4 pH 4.5 (65:35%v/v) at a flow rate of 1ml/min. The developed method was successfully validated as per ICH Q2(R1) guidelines.
Vidhi Dave * and Paresh U. Patel
Department of Quality Assurance, S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva, Gujarat, India.
31 May 2022
15 July 2022
03 August 2022
01 February 2023