Development and validation of analytical methods for quality control of empagliflozin tablets and preliminary stability study
Abstract
Diabetes mellitus (DM) is a disease characterized by a heterogeneous group of metabolic disorders, which present hyperglycemia in common. Different classes of oral antidiabetics, such as empagliflozin, belonging to the class of cotransport inhibitors of sodium-glucose 2 (SGLT-2), are available for treatment. The drug was approved for use in 2014 for the treatment of diabetes mellitus type 2 (DM2), and there are no pharmacopoeial monographs for its determination as raw material and/or tablets. Thus, the focus of this work was the development and validation of qualitative and quantitative methods for the quality control of empagliflozin tablets. The chemical reference substance (SQR) was characterized by methods such as ultraviolet (UV) spectrophotometry, infrared (IV) spectrophotometry, differential scanning calorimetry (DSC) and mass spectrometry. For the identification of the empagliflozin in the tablets, qualitative methods were performed: spectrophotometry (UV), thin layer chromatography (CCD) and capillary electrophoresis (CE). For the quantitative analysis of the tablets, a micellar electrokinetic (MEKC) method was developed and validated using silica capillary (40 cm effective length and 50 μm internal diameter), maintained at 28ºC, voltage +28 kV, hydrodynamic injection of 50 mBar for 4 seconds using electrolytic solution composed of 20 mM tris hydroxymethyl amino methane buffer and 100 mM sodium dodecyl sulfate (SDS) (1:1) pH 10, with detection at 225 nm. The…
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