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

Abstract

Herein, a sensitive and reliable eco-friendly TLC-spectrodensitometric method has been established for the simultaneous determination of dapagliflozin (DAPA) and rosuvastatin (ROSV) for the first time. TLC separation was carried out on silica gel F₂₅₄ using ethyl acetate : methanol (5 : 0.1, v/v) as a mobile phase and UV measurement at 243 nm. The method was fully validated according to ICH guidelines. Acceptable separation was achieved with R_f values of 0.23 and 0.44 for DAPA and ROSV, respectively. Regression plots revealed linear relationships in the concentration range 20–2500 ng per band and 10–2500 ng per band with LODs of 6.60 and 3.57 ng per band for both DAPA and ROSV, respectively. The relative standard deviations (RSDs%) were found to be 1.35 and 0.53 for DAPA and ROSV, respectively. Moreover, kinetic studies were conducted for measurement of degradation rate constant (k) and half life time (t_1/2) of DAPA and ROSV via forced photo-degradation.