Abstract

The binary formulations consisting of dapagliflozin with sitagliptin and vildagliptin are prescribed for the management of diabetes. The current study presents novel eco-friendly ultraviolet spectrophotometric methods for concurrent quantification of dapagliflozin with sitagliptin or vildagliptin in their binary formulations. The ratio spectra of series of sitagliptin, vildagliptin, and dapagliflozin were generated using dapagliflozin 7.5 µg/mL, sitagliptin 10 µg/mL, and vildagliptin 10 µg/mL as divisor than the ratio difference and ratio first derivative techniques were established. Also, the parent spectra of analytes were extracted from the mixture spectrum by successive mathematical filtration for quantification of individual analytes from the binary mixture without prior separation. The procedure showed good correlation in the series of 5–100 µg/mL for sitagliptin, 7.5–75 µg/mL for vildagliptin, and 1–15 µg/mL for dapagliflozin with an excellent correlation coefficient and good levels of detection and quantification. For the quantification of dapagliflozin levels in combination with different analytes, a single calibration curve was constructed. To create repeatable methods, the wavelength selection for measuring the peak amplitude and analyte concentration of divisor spectra was carefully optimized. The explored methods showed a low relative error percentage of 0.44–1.52, 0.20–0.94, and 0.02–1.22 and relative standard deviation percentages of 0.47–1.44, 1.16–1.41, and 0.94–1.81 for SGT, VGT, and DAP respectively, which confirmed the trueness and precision of the established processes. The validity of the ultraviolet methods was confirmed by quantifying the laboratory mixtures with varying dapagliflozin, sitagliptin, and vildagliptin ratios in addition to the standard addition technique. Additionally, the method's greenness evaluated by hexagonal and AGREE models and whiteness by the red–greenblue model demonstrated greater environmental sustainability in terms of safety and waste generated. Thus, utilizing environmentally friendly UV spectrophotometric techniques, a binary formulation including dapagliflozin + sitagliptin and dapagliflozin + vildagliptin can be evaluated for routine quality control.

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