title: Stability-Indicating Assay for the Determination of Pentobarbital Sodium in Liquid Formulations.
abstract: A stability-indicating assay by reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of pentobarbital sodium in oral formulations: a drug used for infant sedation in computed tomography (CT) or magnetic resonance imaging (MRI) scan. The chromatographic separation was achieved on a reversed-phase C18 column, using isocratic elution and a detector set at 214 nm. The optimized mobile phase consisted of a 0.01 M potassium buffer pH 3 and methanol (40 : 60, v/v). The flow rate was 1.0 mL/min and the run time of analysis was 5 min. The linearity of the method was demonstrated in the range of 5 to 250 μg/mL pentobarbital sodium solution (r (2) = 0.999). The limit of detection and limit of quantification were 2.10 and 3.97 μg/mL, respectively. The intraday and interday precisions were less than 2.1%. Accuracy of the method ranged from 99.2 to 101.3%. Stability studies indicate that the drug is stable to sunlight and in aqueous solution. Accelerated pentobarbital sodium breakdown by strong alkaline, acidic, or oxidative stress produced noninterfering peaks. This method allows accurate and reliable determination of pentobarbital sodium for drug stability assay in pharmaceutical studies.
authors.affiliation: Service Pharmacie, AP-HP Hôpital Jean-Verdier, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France.
authors.forename: Myriam
authors.initials: M
authors.lastname: Ajemni
authors.affiliation: Service Pharmacie, AP-HP Hôpital Jean-Verdier, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France.
authors.forename: Issa-Bella
authors.initials: IB
authors.lastname: Balde
authors.affiliation: Service Pharmacie, AP-HP Hôpital Jean-Verdier, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France.
authors.forename: Sofiane
authors.initials: S
authors.lastname: Kabiche
authors.affiliation: Service Pharmacie, AP-HP Hôpital Jean-Verdier, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France.
authors.forename: Sandra
authors.initials: S
authors.lastname: Carret
authors.affiliation: Service Pharmacie, AP-HP Hôpital Jean-Verdier, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France.
authors.forename: Jean-Eudes
authors.initials: JE
authors.lastname: Fontan
authors.affiliation: Service Pharmacie, AP-HP Hôpital Jean-Verdier, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cisternino
authors.affiliation: Service Pharmacie, AP-HP Hôpital Jean-Verdier, Hôpitaux Universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France.
authors.forename: Joël
authors.initials: J
authors.lastname: Schlatter