Development and Validation of Tandem UV Spectroscopic Methods for Simultaneous Estimation of Dapagliflozin and Vildagliptin in Its Bulk and Combined Dosage Form

Dapagliflozin and Vildagliptin are type 2 antidiabetic drugs in which Dapagliflozin is a highly selective sodium-glucose cotransporter-2 inhibitor, and Vildagliptin functions as a dipeptidyl peptidase-4 (CD26) inhibitor. This research article proposes a specific tandem spectroscopy approach verified for the assessment of Dapagliflozin and Vildagliptin in their individual and combined pharmaceutical formulations. Method A (absorption correction), where the absorption maximum for Dapagliflozin was 223 nm, also showed absorbance at 276 nm, while the absorption maxima for vildagliptin occur at the same wavelength as the solvent peak, the detection wavelength was thus selected at 223 nm with a zero absorbance at 276 nm. The developed technique exhibited good linearity, ranging from 4–36 µg/mL for Dapagliflozin as well as 40–360 µg/mL for Vildagliptin, exhibiting a high degree of correlation (R² = 0.9964) for Dapagliflozin and (R² = 0.9991) for Vildagliptin. Method B (double point standardization method), Vildagliptin shows absorption maxima in the end UV region, thus, for avoiding interference with solvent peaks, the peak of Vildagliptin was shifted to the visible region by using bromocresol green. Ethanol was used as a solvent. The absorption maxima of Dapagliflozin and Vildagliptin were found to be 278 and 622 nm, respectively. The developed method showed good linearity, ranging from 20–52 µg/mL for Dapagliflozin as well as 200–520 µg/mL for Vildagliptin, and it exhibited a high degree of correlation (R²= 0.9989) for Dapagliflozin and (R²= 0.9996) Vildagliptin. Both methods exhibited good linearity, accuracy, and precision, with a low percent relative standard deviation, and they both demonstrated better recovery and reproducibility. A sensitivity test was performed by calculating the LOD and LOQ. 

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