Background: Type II diabetes is treated with linagliptin and dapagliflozin. Dapagliflozin works by
specifically blocking the sodium-glucose co-transporter-2 (SGLT-2) protein, while linagliptin belongs
to the dipeptidyl peptidase-4 (DPP-4) inhibitor class, a relatively new and developing class of
medications.
Materials and Methods:
The aim of this study was to develop and validate a straightforward, accurate, and stable reversed-phase
liquid chromatographic (RP-HPLC) method for determining the combination pharmaceutical dosage
form of dapagliflozin and linagliptin, along with a stability-indicating assay. Forced degradation studies
involving acid and base hydrolysis, oxidation, heat, and photodegradation were conducted on linagliptin
and dapagliflozin. Separation and forced degradation were achieved using a reversed-phase Nova (C18,
250 mm x 4.6 mm, 5 ?m) column and isocratic elution. The eluent consisted of methanol and phosphate
buffer (65:35 % v/v), with the pH adjusted to 4.0 using ortho phosphoric acid, and a flow rate of 1
mL/min. Detection was performed at 226 nm with a photodiode array detector.
Findings:
The method effectively separated linagliptin, dapagliflozin, and their breakdown products. It
demonstrated suitable accuracy, linearity, and precision for concentration ranges of 4–40 ?g/mL for
linagliptin and 8–80 ?g/mL for dapagliflozin.Conclusion:
The proposed method is innovative, straightforward, accurate, specific, sensitive, quick, and
economically feasible, as it does not require any prior separation operations. It can be used for the
simultaneous determination of dapagliflozin and linagliptin in tablet formulations.
Keywords: Dapagliflozin, Linagliptin, Chromatography, Force degradation, Diabetes
Publication date: 01/01/2026
https://ijbpas.com/pdf/2026/January/MS_IJBPAS_2026_9798.pdf
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https://doi.org/10.31032/IJBPAS/2026/15.1.9798
