Please cite this article in press as: Dreno C, et al. Formulation and stability study of a pediatric 2% phenylephrine hydrochloride eye drop solution. Ann Pharm Fr (2014), http://dx.doi.org/10.1016/j.pharma.2014.06.006 ARTICLE IN PRESS +Model PHARMA-366; No. of Pages 6 Annales Pharmaceutiques Françaises (2014) xxx, xxx—xxx Disponible en ligne sur www.sciencedirect.com ORIGINAL ARTICLE Formulation and stability study of a pediatric 2% phenylephrine hydrochloride eye drop solution Formulation et étude de stabilité d’un collyre pédiatrique de chlorhydrate de phényléphrine à 2 % C. Dreno a , T. Gicquel b , M. Harry c , O. Tribut d , F. Aubin c , N. Brandhonneur e , G. Dollo a,e,* a Pôle pharmaceutique, CHU Pontchaillou, 2, rue Henri-Le-Guilloux, 35033 Rennes cedex 9, France b Laboratoire de toxicologie biologique et médico-légale, CHU Pontchaillou, 2, rue Henri-Le-Guilloux, 35033 Rennes cedex 9, France c Pôle pharmaceutique, hôpital Sud, CHU de Rennes, 16, boulevard de Bulgarie, 35203 Rennes cedex 2, France d UF biomarqueurs, CHU Pontchaillou, 2, rue Henri-Le-Guilloux, 35033 Rennes cedex 9, France e Laboratoire de pharmacie galénique, biopharmacie et pharmacie clinique, faculté des sciences pharmaceutiques et biologiques, université Rennes-1, 2, avenue du Pr-Léon-Bernard, 35043 Rennes cedex, France Received 18 April 2014; accepted 18 June 2014 KEYWORDS Phenylephrine hydrochloride; Eye drop; Premature infant; Biocompatibility; Stability study; Mass spectrometry Summary Introduction. — We present formulation and stability evaluation of a 2% (w/v) phenylephrine hydrochloride biocompatible eye drop solution, routinely prepared in hospital pharmacy under aseptic conditions, for retinal examination of neonates and premature infants. Materials and methods. — Eye drop solution was formulated by dissolution of phenylephrine hydrochloride and disodium hydrogen phosphate as buffering agent in sterile water for injection and sodium chloride for injection as isotonic agent. The previous solution was sterile filtered through under aseptic conditions, in an iso class 5 air quality clean room under horizontal laminar airflow hood. Physical stability (visual inspection, osmolality measurements), chemical stability (pH measurement, phenylephrine assay by liquid chromatography coupled with an ∗ Corresponding author. E-mail addresses: gilles.dollo@univ-rennes1.fr, gilles.dollo@chu-rennes.fr (G. Dollo). http://dx.doi.org/10.1016/j.pharma.2014.06.006 0003-4509/© 2014 Elsevier Masson SAS. All rights reserved.