Abstract
Objective: The aim of the present work is the development of new, sensitive, specific, and accurate high-performance liquid chromatographic method for the separation and determination of dapagliflozin and its impurities in tablet dosage form.
 Methods: The chromatographic separation of drug and its impurities was achieved using Hypersil BDS C18 column (250 mm × 4.6 mm, 5 μ) with mobile phase consisted of mobile phase-A (Buffer pH 6.5) and mobile phase-B (acetonitrile:water 90:10) by gradient program at a flow rate of 1 mL/min with ultraviolet detection at 245 nm.
 Results: Dapagliflozin and its impurities A, B, C, D, E, and impurity-F were successfully eluted at the retention time of 16.95, 2.72, 7.82, 10.58, 21.11, 30.37, and 34.36 min, respectively, with good resolution. The method was validated according to the international conference on harmonization guidelines. The validation results showed good precision, accuracy, linearity, specificity, sensitivity, and robustness.
 Conclusion: Successful separation and determination of dapagliflozin and its six impurities were achieved by the proposed method. The developed method can be applied for the routine analysis of dapagliflozin and its impurities in pharmaceutical formulations.
Highlights
Dapagliflozin is an antidiabetic drug used for the management of type 2 diabetes mellitus and belongs to a novel class called sodium glucose cotransporter 2 (SGLT2) inhibitor
The retention time (RT) of the drug and the impurities were identified by analyzing the chromatograms (Fig. 1) of individual standard solutions of dapagliflozin and the impurities in five replicates under the optimized method conditions
The quality and safety of the drug product depends on the adopted manufacturing procedure and toxicological properties of an active substance and depends on the impurities that it contains
Summary
Dapagliflozin is an antidiabetic drug used for the management of type 2 diabetes mellitus and belongs to a novel class called sodium glucose cotransporter 2 (SGLT2) inhibitor. It is a potent, competitive, reversible, highly selective, and orally active inhibitor of SGLT2, the major transporter protein responsible for the renal glucose reabsorption. Dapagliflozin’s mechanism of action is different from the mechanisms of other antidiabetic drugs as it involves the direct and insulin-dependent elimination of glucose by the kidney. It is a synthetic aryl glycoside contains multiple chiral centers, but the drug is a single enantiomer and it is chemically described as (2S, 3R, 4R, 5S, 6R)-2-(4-chloro-3-[4-ethoxybenzy] phenyl)-6-(hydroxyl methyl) tetrahydro-2H-pyran-3,4,5-triol [1,2,3]
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