Estimation of Dapagliflozin from its Tablet Formulation by UV-Spectrophotometry

Abstract

Aim: Simple, precise and accurate UV-spectrophotometric methods for estimation of Dapagliflozin were developed and validated as per ICH guidelines. Experimental and Results: These methods includes Calibration curve, Area under curve (AUC), First and Second order derivative method based on measurement of absorbance at a selected wavelengths using UV-visible spectrophotometer with 1 cm matched quartz cell and methanol with water as a solvent. All developed methods obeyed Beer’s-lambert’s law in the concentration range of 5-40 μg/mL, with correlation coefficient value less than 1. The percent amount of drug estimated by these methods was nearly 100%, found to be in good agreement with label claim of marketed tablet formulation. The recovery study was carried out at five different levels and results were found to be satisfactory. Conclusion: The results of estimation and validation parameters like accuracy, precision, ruggedness, linearity and range were studied for all the developed methods and were found to be within limits. The proposed method can be adopted for routine quality control for estimation of drug in formulation.