天美传媒

Abstract

Background: Structurally similar to phencyclidine (PCP), ketamine hydrochloride is widely used for treatment in patients with resistant depression, as an anesthetic for surgical procedures, and more. The usage of ketamine infusions has increased in recent years. However, with a lack of extended stability information, it is difficult to determine if ketamine is safe to administer if diluted and stored for extended periods of time.

Objective: To evaluate the stability of ketamine hydrochloride infusion in 0.9% normal saline while in controlled ambient conditions.

Methods: A High-Pressure Liquid Chromatography (HPLC) analysis was performed after each time point to determine stability of Ketamine Hydrochloride 500mg diluted in 50ml of normal saline. An infusion was considered stable if the area under the curve was within the USP acceptable range of 95-105%.

Results: All samples remained physically unchanged over time. For all ketamine infusions, after each time point, the HPLC analysis was within 95-105%. Additionally, the analysis showed negative sterility samples and the pH remained stable throughout the study.

Conclusion: This study shows Ketamine HCL is stable in concentrations up to 10mg/ml in polyvinyl chloride (PVC) under ambient conditions for a maximum of 90 days.