A novel, simple, sensitive and less time consumption RP-HPLC has been developed and validated for impurity profiling of dapagliflozin propandiol monohydrate as raw material. The method used BDS Hypersil C18 (150mm, 4.6mm, 5µm). The mobile phase consisted of A (Phosphate Buffer adjusted pH to 3.2 using orthophosphoric acid) and B (Acetonitrile). Gradient elution system has been used with 1mL/min flow rate. Detection was carried out using PDA at 240nm. The results of this method showed the presence of an impurity exceeding 0.1% in one of the samples marketed for the active substance then this impurity was isolated by preparative chromatography technique and its structure was determined using FTIR spectroscopy, H1-NMR, C13-NMR spectroscopy, and MS mass spectrometry. Isolated impurity has been identified as dapagliflozin tetraacetate, which is one of the intermediate products in the preparation of this active pharmaceutical ingredient (API).
Tishreen University Journal for Research and Scientific Studies .
2022.
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