Abstract

Background and Objective: A combination of empagliflozin and linagliptin in a fixed dosage was employed for treating individuals with a diagnosis of type 2 diabetes mellitus. A rapid, accurate, and sensitive liquid chromatography-tandem mass spectrometry method was devised and validated for simultaneous measuring empagliflozin and linagliptin levels in human plasma. This method provides a good analytical tool for bioequivalence and pharmacokinetic studies.

Methods: The separation was conducted employing a C8 column using a mobile phase consisting of acetonitrile (ACN, 2.5mM) and ammonium chloride (55:45). Optimal detection of the analytes and their deuterated internal standards was accomplished through electrospray ionization in the positive mode.

Results: Validation of standard curve concentrations linearity was carried out within the ranges of 1.500 – 500.000 ng/mL for empagliflozin and 0.050 – 7.000 ng/mL for linagliptin. Both drugs showed intra-batch and inter-batch precision (CV%) of less than 3.7%. The stability of the drugs was confirmed under various storage conditions, proving suitability for routine laboratory analysis.

Conclusion: This validated method is appropriate for pharmacokinetic studies and large-scale analysis with high precision and accuracy.

Keywords: Empagliflozin, linagliptin, LC-MS/MS, protein precipitation, validation, pharmacokinetic, bioequivalence.