Stability Indicating HPTLC Method for Simultaneous Estimation of Empagliflozin and Linagliptin in Pharmaceutical Formulation

A high-performance thin-layer chromatographic method was developed and validated for simultaneous determination of Empagliflozin and Linagliptin. The proposed method was applied successfully to the pharmaceutical analysis of the recently approved dosage form, Glyxambi tablets. The drugs were satisfactorily resolved with RF 0.22 for Linagliptin and 0.57 for Empagliflozin. Method was validated according to the ICH guidelines. The calibration plot was linear between 0.2 -1.2 μg per band for Empagliflozin and 0.1-0.6 μg per band for Linagliptin. The LOD and LOQ for Empagliflozin and Linagliptin were 1.678 and 1.565 μg per band, for l they were 1.56 and 1.46 μg perband, respectively. Accuracy and precision of the proposed method was evaluated by recovery studies (% recovery for Empagliflozinand Linagliptin was 99.71% and 99.64%, respectively) and intra-day and inter-day precision studies (standard deviation for precision studies was below 2), respectively. In stability testing, Empagliflozin and Linagliptin were found susceptible to acid hydrolysis and alkaline degradation. Because the method could effectively separate the drugs from their degradation products, it can be used as a stability indicating method. The proposed validated stability indicating assay for the sensitive determination of the mentioned drugs is suitable for Quality control laboratories as a simple fast economic method.