International Journal of Drug Delivery Technology
Volume 14, Issue 3

Stability-Indicating HPLC Method Development and Validation for the Simultaneous Determination of Vildagliptin and Dapagliflozin in Pharmaceutical Dosage Form

Deshmukh S B1, Wagh P A1, Yadav S S2*, Mane M B2

1Department of Quality Assurance Techniques, Bharati Vidyapeeth (Deemed to be University), Poona College of Pharmacy, Erandwane, Pune, India.

2Department of Pharmaceutical Chemistry, Bharati Vidyapeeth (Deemed to be University), Poona College of Pharmacy, Erandwane, Pune, India. 

Received: 24th February, 2024; Revised: 18th April, 2024; Accepted: 10th June, 2024; Available Online: 25th September, 2024 

ABSTRACT

Vildagliptin (VD) and Dapagliflozin (DP) were determined simultaneously by RP-HPLC using an ultraviolet (UV) detector, a Hypersil Gold C18 (250 × 4.6 mm) column, 5 µm and a mobile phase of acetonitrile: water (adjusted with O-Phosphoric acid to pH 3) in ratio 40: 60% v/v. The estimation wavelength was chosen to be 213 nm. VD and DP were shown to have retention times of 2.9 and 8.3 minutes, respectively. Q2 (R1) ICH guidelines were followed during the validation process. VD and DP correlation coefficient R2 values are 0.9993 and 0.999, respectively. While DP’s linearity range is 1 to 6 µg/mL, VD’s is 10 to 60 µg/mL. The precision and accuracy studies show %relative standard deviation (%RSD) below 2%. Recovery% was assessed to meet the ICH Q2 (R1) guidelines criteria. The presented research on forced degradation showed stability indicating studies. The findings also demonstrated that the suggested method is suitable for determining VD and DP precisely and accurately.

Keywords: Vildagliptin, Dapagliflozin, Forced degradation studies, Validation.

International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.3.49

How to cite this article: Deshmukh SB, Wagh PA, Yadav SS, Mane MB. Stability-Indicating HPLC Method Development and Validation for the Simultaneous Determination of Vildagliptin and Dapagliflozin in Pharmaceutical Dosage Form. International Journal of Drug Delivery Technology. 2024;14(3):1599-1603.

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