Estimation Method for Dapagliflozin in Bulk and Marketed Dosage Form: Development and Validation by UV-Spectroscopy

Download PDF

The present study aimed to develop a novel and sensitive method for spectrophotometric estimation in the UV region for the determination of dapagliflozin in its tablet formulation and to validate all analysis parameters according to ICH guidelines. Dapagliflozin was found to show its λ max at 220 nm using a UV-Vis spectrophotometer with a 1 cm quartz cell and methanol: water in the ratio of 15:85 for the preparation of stock solution (1000 μg/ml) and distilled water was used for further dilutions, for the preparation of working solutions. The technique used followed Beer's Lambert's law in the concentration range of 5–30 µg/ml, with a correlation value of 0.999. The limits of detection (LOD) and quantification (LOQ) were 0.623 µg/ml and 1.889 g/ml, respectively. The estimated percentage of the drug was nearly 103%, in good agreement with the marketed dosage form label (Udapa*10). Recovery experiments were carried out at three distinct levels, and the results were determined to be good. Furthermore, the findings of the methodologies devised for robustness and roughness are within their limitations. The suggested method is inexpensive, simple to use, and appropriate for regular analysis of dapagliflozin in bulk and commercial dose forms.