Degradation Study of Dapagliflozin in API by Spectro-scopic Method
Keywords:
Dapagliflozin, UV- Spectroscopy, API, International Conference on HarmonizationAbstract
A simple, sensitive, precise, accurate, economic and rapid visible spectroscopic method has been developed for estimation of dapagliflozin in API.Dapagliflozin was subjected to different stress conditions as per ICH guideline Q1A (R2). A stability- indicating UV Spectroscopic method has been developed for analysis of the drug in the presence of the degradation products. Degradation of Dapagliflozin was studied in acid, alkaline, hydrogen peroxide, photolytic, thermal and neutral conditions. The amount of degraded drug was calculated by taking absorbance at 272 nm.The drug was found to be more liable to decompositions in acidic,alkaline,oxidative , neutral medium than in photolytic and thermal conditions.
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