Long-term stability of 10mg/mL dobutamine injectable solutions Dataset

Published: 2 November 2020| Version 1 | DOI: 10.17632/cxs7y94kj8.1
Contributors:
Sixtine Gilliot,
Héloïse Henry,
Natacha Carta,
Stéphanie Genay,
Christine Barthélémy,
Bertrand Décaudin,
Pascal Odou

Description

This dataset describes the raw and analyzed data of a stability study whose aim was to compare the stability of 10mg/mL ready-to-use dobutamine solutions when stored in either polypropylene syringes or cyclic-oleofin copolymer vials, diluted either in dextrose 5% in water or normal saline solution and stored in a dark enclosure at either frozen (-20±5°C), refrigerated (+5±3°C) or ambient temperatures (+25±2°C with 60±5% relative humidity for 12 months. Calibration solutions were prepared by diluting stock solutions with dextrose 5% in water (D5W) or normal saline solution (NS) to obtain eight different standard levels: 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.3, 1.5 mg/mL (n=6)

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Products Drug : 250mg/20mL hydrochloride dobutamine commercial solution (Panpharma, Luitre, France) Containers : 50mL COC-vials (AT-Closed® vials, Aseptic Technologies, Gembloux, Belgium) and 50mL luer-lock PP-syringes (Plastipak, Becton Dickinson, Le Pont-de-Claix, France). Method We developed a reversed-phase liquid chromatography coupled with a UV detection stability-indicating method. The system (Agilent® 1260 Infinity LC, Les Ulis, France) was equipped with a C18 column (Kinetex 5 µm, 150 x 4.6 mm, Phenomenex, Le Peck, France) maintained at +25°C. The wavelength of the UV detector (1260 MWD DEAAZ00942) was set at 280 nm according to the European Pharmacopeia. The mobile phase A/B/C 84/4/12% (v/v) with isocratic elution (1.8mL/min) was used. This mobile phase was prepared with 0.1 mM sodium acetate buffer [A], pH adjusted to 4.0, methanol [B] and acetonitrile [C]. 1. Calibration Concerning the validation of the stability-indicating method, calibration solutions were prepared by diluting stock solutions with dextrose 5% in water (D5W) or normal saline solution (NS) to obtain eight different standard levels: 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.3, 1.5 mg/mL (n=6). 2. Chemical stability assay After validation of the dosage method, stability was assessed by measuring dobutamine concentration in 320 syringes and 640 vials at 16 time points. Each syringe or vial was only used once for analysis and had been prepared to contain dobutamine at a concentration of 10mg/mL either with dextrose 5% in water or normal saline solution and stored in a dark enclosure at either frozen (-20±5°C), refrigerated (+5±3°C) or ambient temperatures (+25±2°C with 60±5% relative humidity). Prepared solutions were diluted at 1/10 with NS or D5W according to the diluent used for their preparation, before injection into the high-performance liquid chromatography system.

Institutions

Universite de Lille, Centre Hospitalier Regional Universitaire de Lille

Categories

Drug Stability

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