Long-term stability of ketamine hydrochloride 50mg/ml injection in 3ml syringes.
BACKGROUND
Ketamine hydrochloride (Ketalar(®)) injection is often used as a general anesthetic agent. It is particularly suited to short-term interventions. It can also be used as an inducer of anesthesia before the administration of other anesthetic agents. The aim of this study was to evaluate the stability of ketamine hydrochloride in 3ml polypropylene syringes after storage for up to 180days at room temperature.


METHODS
Syringes containing ketamine hydrochloride (50mg/ml) were prepared and stored at room temperature (25°C) for 180days. The concentrations were measured by validated ultra-performance liquid chromatography-diode array detection at 0, 7, 14, 28, 60, 84, 112, 140 and 180days. A degradation test was performed to evaluate the specificity of the analysis. At each time point, the pH, color and visible particles of each solution were also assessed.


RESULTS
Degradation tests proved no interfering peaks with ketamine. All solutions were physically stable during the storage. The lower confidence limit of the concentration for these solutions remains superior to 90% of the initial concentration at this date as recommended by the Food and Drug Administration (FDA) until 180days (100%±2%).


CONCLUSIONS
Solutions of ketamine (50mg/ml) were chemically stable for 180days in polypropylene syringes with storage at room temperature and could be prepared in advance by a centralized intravenous admixture service.
Medical Laboratory, CHU Dinant Godinne, UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
S
S
Huvelle
Medical Laboratory, CHU Dinant Godinne, UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium; Drug Stability Research Group, CHU Dinant Godinne, UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
M
M
Godet
Department of Pharmacy, CHU Dinant Godinne, UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium; Drug Stability Research Group, CHU Dinant Godinne, UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium. Electronic address: jean-daniel.hecq@uclouvain.be.
J-D
JD
Hecq
Department of Pharmacy, CHU Dinant Godinne, UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
P
P
Gillet
Scientific Support Unit, CHU Dinant Godinne, UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
B
B
Bihin
Scientific Support Unit, CHU Dinant Godinne, UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
J
J
Jamart
Medical Laboratory, CHU Dinant Godinne, UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium; Drug Stability Research Group, CHU Dinant Godinne, UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
L
L
Galanti
D000778:Anesthetics, Dissociative / Q000008:administration & dosage / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D007267:Injections; D007649:Ketamine / Q000008:administration & dosage / Q000032:analysis*; D019999:Pharmaceutical Solutions / Q000032:analysis; D013594:Syringes
D000778:Anesthetics, Dissociative; D019999:Pharmaceutical Solutions; D007649:Ketamine
Centralized intravenous admixtures services; Chromatographie liquide à ultra performance; Ketamine; Kétamine; Ultraperformance liquid chromatography; Unité centrale de reconstitution d’injectables