International Journal of Drug Delivery Technology
Volume 15, Issue 1

Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Assessment of Dapagliflozin and Metformin in their Pure Forms and in Presence of Selected Excipients 

Pearl Patel1, Bhavik Jani2, Usman Gani Chalotiya3, Hiral Dave1* 

1Parul Institute of Pharmacy, Parul University, P.O. Limda, Waghodia, Vadodara, Gujarat -391760, India

2Innovative Analytical Laboratory, Vapi, Gujarat – 396191, India

3Indukaka Ipcowala College of Pharmacy, New V V Nagar, Anand, Gujarat – 388121, India 

Received: 10th Sep, 2024; Revised: 13th Dec, 2024; Accepted: 23rd Dec, 2024; Available Online: 25th Mar, 2025

ABSTRACT

Excipients are crucial in formulating dosage forms. However, under stressful environmental conditions, they might interact with the active pharmaceutical ingredient, potentially diminishing the drug's efficacy. The present research article investigates the crucial role of excipients, with a key focus on compatibility evaluations of Dapagliflozin and Metformin with selected excipients mixture, including Polyvinaylpyrolidon K90F, microcrystalline cellulose, Croscarmellose sodium and Magnesium stearate. The analysis used an Inertsil ODS-3V column. The mobile phase, consisting of Water: Methanol in the ratio of 25:75v/v. The pH of the mobile phase was adjusted to 3 using orthophosphoric acid. The detection was done at 225nm. The range value for Dapagliflozin and Metformin were observed as 20-80μg/mL and 0.4-1.6μg/mL, respectively with the respective retention time of 2.1 for Metformin and 8.9 for Dapagliflozin. A forced degradation study was performed on Dapagliflozin and Metformin, in their pure forms and in combination with selected excipients and formulations. The comparison of effects of stress conditions were observed and concluded in the presence of selected excipients and in the commercially available formulation containing Dapagliflozin and Metformin. The extensive evaluation of Dapagliflozin and Metformin compatibility with selected excipients under various conditions offered valuable insights into their stability and practical utility.

Keywords: Dapagliflozin, Metformin, Forced degradation, RP-HPLC, Diabetic mellitus

How to cite this article: Pearl Patel, Bhavik Jani, Usman Gani Chalotiya, Hiral Dave. Development and Validation of Stability Indicating RP-HPLC method for Simultaneous assessment of Dapagliflozin and Metformin in their pure forms and in the presence of selected excipients. International Journal of Drug Delivery Technology. 2025;15(1):99-105. doi: 10.25258/ijddt.15.1.13

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