Producción CyT
Artículo
Autoría
Laura F. Suchetti
;
Viviana Dabbene
;
TEMPESTI, TOMAS CRISTIAN
;
Carlos G. Ferrayoli
Fecha
2025
Editorial y Lugar de Edición
Wiley-VCH GmbH
Revista
SEPARATION SCIENCE PLUS
Wiley-VCH GmbH
Resumen
Información suministrada por el agente en
SIGEVA
A rapid and stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method with UV detection (210 nm) was developed for the evaluation of chromatographic purity and the analysis of glycerol phenylbutyrate in the pharmaceutical formulation. In this method, a C18 analytical column was used at room temperature with a mobile phase containing a mixture of acetonitrile and water (90:10, v/v) at a flow rate of 1.0 mL/min. The forced degradation study was evaluated accordin...
A rapid and stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method with UV detection (210 nm) was developed for the evaluation of chromatographic purity and the analysis of glycerol phenylbutyrate in the pharmaceutical formulation. In this method, a C18 analytical column was used at room temperature with a mobile phase containing a mixture of acetonitrile and water (90:10, v/v) at a flow rate of 1.0 mL/min. The forced degradation study was evaluated according to the International Conference on Harmonization. The procedure was validated for linearity, accuracy, solution stability, specificity, precision (repeatability and intermediate precision), and robustness in accordance with current guideline requirements and was reported as reliable and suitable for the intended application.
Ver más
Ver menos
Palabras Clave
STABILITY INDICATINGGLYCEROL PHENYLBUTYRATEFORCED DEGRADATIONVALIDATIONHPLC