Assay of empagliflozin tablets by a stability-indicating micellar electrokinetic chromatography method and cytotoxicity study of degraded samples
| Autor: | Clarice Madalena Bueno Rolim, Ana Paula Guarnieri Christ, Andréa Inês Horn Adams, Daniele Rubert Nogueira Librelotto, Pauline Trindade Biscaino |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Tris
Chromatography Sodium Kinetics Empagliflozin chemistry.chemical_element Degradation kinetics Electrolyte Factorial experiment Micellar electrokinetic chromatography Capillary electrophoresis RS1-441 chemistry.chemical_compound Pharmacy and materia medica chemistry Cellular viability Validation Hydroxymethyl |
| Zdroj: | Brazilian Journal of Pharmaceutical Sciences, Vol 57 (2021) Brazilian Journal of Pharmaceutical Sciences, Volume: 57, Article number: e18903, Published: 11 OCT 2021 |
| ISSN: | 2175-9790 |
| Popis: | The first method by micellar electrokinetic chromatography (MEKC) for the determination of empagliflozin in tablets was developed and validated following the ICH guidelines. The separation was achieved in a fused silica capillary with 50 µm x 40 cm (inner diameter x effective length) at 28 oC, +28 kV voltage, hydrodynamic injection 4s (50 mBar), detection at 225 nm and paracetamol was the internal standard. The running electrolyte was a mixture of 20 mM tris(hydroxymethyl)aminomethane (pH 10) and 100 mM sodium dodecyl sulphate (1:1). Specificity was evaluated by the stress testing and the method was specific, with no interference of the degradation product. Linearity was observed in the range of 50 to 150 μg/mL (r=0.9999). The method showed adequate accuracy (recovery value=100.60±0.60%), precision (RSD values |
| Databáze: | OpenAIRE |
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