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.

Stability of Pentobarbital Hydrogel for Rectal Administration in Pediatric Procedural Sedation

“…There was neither interference nor overlap between pentobarbital and their degradation products. As described in the stability-indicating study of Ajemini et al, 13 the drug was found to be highly stable under standard (1N HCl, 1N NaOH) stress conditions with at least 98% of remaining drug. Under high acidic and alkaline (12N HCl, 10N NaOH) stress conditions, 3 degradation products were identified as 1 for acidic condition and 2 for alkaline condition.…”

“…The pentobarbital content was determined using the stability-indicating HPLC method previously published by Ajemni et al 13 Analysis was performed on a Dionex Ultimate 3000 system (Thermo Fisher, Villebon-sur-Yvette, France). The chromatographic separation was performed on a Pursuit 5 C18 (250 × 4.6 mm, 5-µm particles; Agilent, Les Ulis, France) column.…”

Development and Stability of a New Formulation of Pentobarbital Suppositories for Paediatric Procedural Sedation

“…The chromatographic separation was performed on an EC 250/4.6 Nucleodur C18 HTec column (250 × 4.6 mm, 5 µm particle size; Macherey-Nagel, Düren, Germany). The pentobarbital content in the suppositories was determined using a stability-indicating HPLC method slightly adapted from a previously published method by Ajemni et al [ 25 ]. In brief, the stationary phase (C18) and the mobile phase (0.01 M phosphate buffer pH3 adjusted with HCl (Phase A) and methanol (Phase B), 40:60, v / v ) were used, but we switched the isocratic elution to a gradient one ( Table 2 ), at a flow rate of 1.2 mL/min; injection volume was 25 µL.…”

Stability data of extemporaneous oral suspension of pentobarbital in Syrspend SF Alka for imaging sedation procedure

“…Pentobarbital concentration was measured using a previously published high-performance liquid chromatography (HPLC) stability-indicating method [12] . HPLC system (Dionex Ultimate 3000, Thermo Scientific, Villebon-sur-Yvette, France) was used with HPG-3200SD quaternary pump, WPS-3000TSL autosampler, and MWD-3000 variable wavelength detector.…”