Development and validation of a stability-indicating RP-HPLC method for simultaneous determination of dapagliflozin and saxagliptin in fixed-dose combination

Abstract

A simple and precise stability indicating method for the simultaneous estimation of dapagliflozin and saxagliptin in combined tablet dosage form was developed and validated using RP-HPLC.

A Review on Analytical Methods of Dapagliflozin: An Update

“…22 Singh et al presented an easy and novel stability method for the combination of dapagliflozin and saxagliptin with buffer (53) and acetonitrile (47) at 230 nm. 23 32 All methods mention above shown in Table 2.…”

TLC-spectrodensitometric method for simultaneous determination of dapagliflozin and rosuvastatin in rabbit plasma: stability indicating assay and kinetic studies

“…During stressed degradation experiments, it was noticed that DAPA and ROSV were more sensitive toward photolysis in water solution than in methanol as, the DAPA is relatively stable in pure methanol, 40,41 and a mixture of a buffer with organic solvent 42 while ROSV is more degradable in pure water than other organic solvent 43,44 at 365 nm, and found that degradation of DAPA depends on the time, but ROSV depends on initial concentration at the same conditions. The degradation rate constant (k) and the regression coefficient (r 2 ) of the two drugs calculated from Table 4.…”

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.…”