Rev. OFIL 2017, 27;3:249-255
Fecha de recepción: 06/01/2017 – Fecha de aceptación: 10/03/2017
Moya-Gil A1, Martínez-Gómez MA2, Climente-Martí M3, Merino-Sanjuán M4
1 Farmacéutica Especilista en Farmacia Hospitalaria. Servicio de Farmacia. Hospital Universitario Dr. Peset. Valencia (España)
2 Doctora en Químicas. Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunidad
Valenciana (FISABIO). Servicio de Farmacia. Hospital Universitario Dr. Peset. Valencia (España)
3 Jefe de Servicio de Farmacia Hospitalaria. Servicio de Farmacia. Hospital Universitario Dr. Peset. Valencia (España)
4 Catedrática. Departamento de Farmacia y Tecnología Farmacéutica. Facultad de Farmacia. Universidad de Valencia (España)
Ana Moya Gil
Hospital Universitario Dr. Peset
(Servicio de Farmacia)
Avda. Gaspar Aguilar, 90
Correo electrónico: firstname.lastname@example.org
Purpose: To assess the chemical stability and physical compatibility of dexamethasone.
Method: Experimental study of 15 days duration. Products: dexamethasone sodium phosphate and NaCl 0.9% 50 ml (Viaflo®). Four samples were prepared in duplicate (0.10, 0.16, 0.38 and 0.89 mg/ml) and stored refrigerated (5±2ºC) with photoprotection (PL) and in presence of light (L). Chemical stability: concentration variation was evaluated using High Performance Liquid Chromatography, calculating T90. Chromatographic method was validated for linearity, precision, accuracy, selectivity and repeatability, detection limit and quantification was also determined. Physical compatibility was assessed: a) color change, turbidity and precipitation; c) loss of volume; c) pH variation.
Results: No changes in color, turbidity, precipitation or loss of volume were observed. The pH variation was ≤2.7% except for sample 1 (5.6%). The chromatographic method was adequate in linearity (r2=0.9997), intra-day and inter-day precision (≤10%), accuracy (≤8%), selectivity (absence of interference), limit of detection (0.020 mg/ml) and quantification (0.068 mg/ml). Chemical stability of all samples of dexamethasone refrigerated PL and L were 10 days, less for the sample of 0,10 mg/ml PL that were 11 days.
Conclusions: The study extends to 10 days the chemical stability and physical compatibility of refrigerated dexamethasone at concentrations 0.10, 0.16, 0.38 and 0.89 mg/ml used as anti-emetic regimen of antineoplastic treatment. This allows early preparation, using stability studies as a Lean tool ensuring quality in the preparation improving efficiency in the Pharmaceutical Oncology Unit.
Key Words: Stability, dexamethasone, antiemetic treatment, Lean.