Development and validation of stability indicating HPTLC method for simultaneous estimation of Dapagliflozin and Linagliptin

Abstract

AbstractFor the treatment of Type 2 Diabetes Mellitus, Dapagliflozin selectively inhibits the sodium-glucose co-transporter-2, while Linagliptin competitively and reversibly inhibits dipeptidyl peptidase-4 in a fixed dose combination (1:1). Dapagliflozin and Linagliptin estimation in bulk and tablet formulation was accomplished by the development and validation of a precise and accurate HPTLC method. The procedure used Toluene: Chloroform: Methanol: Triethylamine (7:2:1:0.2 v/v/v) as the mobile phase and HPTLC aluminum plates pre-coated with silica gel 60 F254 as the stationary phase used. Dapagliflozin and Linagliptin were determined to have Rf values of 0.23 and 0.40 correspondingly. At 224 nm, densitometric analysis was performed in the absorbance mode. For Dapagliflozin and Linagliptin 200–1200 ng/band were the linear ranges in which the procedure produced results. Forced degradation studies were performed on both Dapagliflozin and Linagliptin active pharmaceutical ingredients like acid hydrolysis, base hydrolysis, chemical oxidation, dry heat and photodegradation studies. Dapagliflozin and Linagliptin are susceptible to acid hydrolysis, base hydrolysis, chemical oxidation while both the chemical substances are stable to dry heat and photolytic studies.