| Journal: | Brazilian Journal of Pharmaceutical Sciences |
| Database: | PERIÓDICA |
| System number: | 000451556 |
| ISSN: | 1984-8250 |
| Authors: | Biscaino, Pauline Trindade1 Christ, Ana Paula1 Librelotto, Daniele Rubert Nogueira1 Rolim, Clarice Madalena Bueno1 Adams, Andréa Inês Horn1 |
| Institutions: | 1Universidade Federal de Santa Maria, Programa de Graduacao em Ciencias Farmaceuticas, Santa Maria, Rio Grande do Sul. Brasil |
| Year: | 2021 |
| Volumen: | 57 |
| Country: | Brasil |
| Language: | Inglés |
| Document type: | Artículo |
| Approach: | Experimental, aplicado |
| English abstract | 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 <2%) and robustness, which was evaluated by a full factorial design 23. Drug degradation kinetics was evaluated in alkaline and acidic conditions and first-order kinetic was observed in both conditions. The cytotoxicity of sample solutions degraded by UVA and UVC radiation, alkaline and acid media were studied as well. A similar cellular viability profile was observed with a slight decrease only in samples degraded by UVC radiation and basic medium |
| Disciplines: | Química |
| Keyword: | Química farmacéutica, Química analítica, Empagliflozina, Electroforesis por capilaridad, Viabilidad celular, Cinética de degradación |
| Keyword: | Medicinal chemistry, Analytical chemistry, Empagliflozin, Capillary electrophoresis, Cell viability, Degradation kinetics |
| Full text: | Texto completo (Ver HTML) Texto completo (Ver PDF) |
