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.

Development and Validation of High-Performance Liquid Chromatographic Method for Determination of Dapagliflozin and Its Impurities in Tablet Dosage Form

“…The objective of the study was to identify and quantify the dapagliflozin and its related impurities A, B, C, D, E, and F [5] (Table 1) in the marketed pharmaceutical formulation. Literature survey revealed that few analytical methods have been reported for the estimation of dapagliflozin alone or in combination with other drugs by ultraviolet (UV) spectrometry [6][7][8][9], high-performance liquid chromatography (HPLC) [10][11][12][13][14][15][16][17][18][19], and LC-mass spectrometry [20]. However, there is no reported method about the separation and determination of dapagliflozin impurities.…”

Second‐derivative synchronous spectrofluorimetric assay of dapagliflozin: Application to stability study and pharmaceutical preparation

“…) that acts as a sodium inhibitor of glucose co‐transporters Based on a survey of the published literature (Supporting Information Tables S1 and S2), some methods described DGF quantification either in its pure form or in its tablet dosage form for use in assays and/or stability studies. These methods included spectrophotometric and chromatographic methods , but suffered from either low sensitivity or difficulty, or high cost of analysis. A new simple, cheap and sensitive method is therefore urgently needed for analysis of DGF in both bulk and its commercially dosage forms to establish as a quality control.…”

“…These methods included spectrophotometric and chromatographic methods [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] , but suffered from either low sensitivity or difficulty, or high cost of analysis. A new simple, cheap and sensitive method is therefore urgently needed for analysis of DGF in both bulk and its commercially dosage forms to establish as a quality control.…”

New spectrofluorimetric analysis of dapagliflozin after derivatization with NBD‐Cl in human plasma using factorial design experiments

“…[1][2][3][4] One of the goals of the present study was to analyze DGF at low levels to be applied as an assay for biological samples (human plasma). There are some reported spectrophotometric methods for DGF assay either in raw material or in its pharmaceutical dosage forms [5][6][7][8][9] , however these methods have low sensitivity and cannot be applied for analysis of DGF in complexed biological samples such as human plasma. In the published literature, there are some reported high performance liquid chromatography (HPLC) methods for analysis of DGF in both its pure and tablet forms, as well as in biological fluids [10][11][12][13][14][15][16][17][18][19] , however the reported HPLC methods are complex and expensive.…”