Chemical Potency of Succinylcholine Chloride Stored in Room-Temperature Syringes
Location
D.P. Culp Center Ballroom
Start Date
4-5-2024 9:00 AM
End Date
4-5-2024 11:30 AM
Poster Number
64
Name of Project's Faculty Sponsor
Stacy Brown
Faculty Sponsor's Department
Pharmaceutical Sciences
Competition Type
Competitive
Type
Poster Presentation
Presentation Category
Health
Abstract or Artist's Statement
Introduction: Succinylcholine chloride is a compound commonly used for neuromuscular blockade for endotracheal intubation, surgery or mechanical ventilation. Typically, the 20mg/mL vials are able to be stored in refrigeration at 2° to 8°C (36° to 46°F) or up to 14 days at room temperature without significant loss of potency, as per the manufacturer’s labeling. Data available on stability ranges from days to months, with some suggesting demonstrated stability at ~6 months in unrefrigerated unopened vials at room temperature and 45 days for syringes prepared onsite (20mg/mL in polypropylene) stored at room temperature. In this study, we will investigate the stability of succinylcholine chloride stored in 1mL aliquots in room temperature syringes. The ability to pre-fill syringes and store at room temperature facilitates timely dosing and may help mitigate dosing errors that could incur when pulling drug product from the bulk container. Methods: In order to investigate drug stability, a quantitative high-performance liquid chromatography (HPLC) method must be developed and validated. The validation for our HPLC method with ultraviolet detection (UV) involved investigation of system suitability, accuracy, precision, and linearity. USP guidelines were used as determining validity of the parameters tested including >2000 theoretical plates, <2 Tailing Factor, <5% Relative Standard Deviation (RSD), and <5% Error across 3 days. Mobile phases included a 0.01% trifluoracetic acid buffer in water (A) and 100% acetonitrile (B). A Waters XBridge C18 column (4.6 x 150 mm, 3.5 micron) was used for an isocratic separation of 60% A and 40% B. The flow rate was maintained at 0.4 mL/min, and the column oven at 30oC. The UV detector wavelength was set to 218nm. Stability analysis will be carried out using 10 vials of 20mg/mL succinylcholine chloride (Manufacturer). There will be 5 vials left as controls and 5 vials drawn into syringes (1mL aliquots) and assay tested at different timepoints over 30 days. Sampling days will include time 0hrs, 24hrs, 48hrs, 72hrs, 7 days, 10 days, 14 days, 21 days, and 30 days. Recovery of succinylcholine will be compared between drug stored in syringes versus the manufacturer’s container. Results: After validation analysis, the accuracy determination produced a % error of 0.54%, 0.17%, and 2.39% for concentrations at 125%, 100%, and 75% respectively. Precision analysis of the data produced an RSD of 2.48%, 4.07%, and 2.51% respectively for concentrations at 125%, 100%, and 75% (Spec NMT 5%). Combined linearity produced a result of R^2 = 0.9991, with a calibration range of 5, 10, 15, 20 and 25 mg/mL. Conclusion: The HPLC-UV method tested achieved precise and accurate results and meets USP criteria for system suitability. Furthermore, it generates linear data within the calibration range of this study. This method will be a useful tool in the investigation of succinyl choline chemical potency over different timepoints in a 30-day period.
Chemical Potency of Succinylcholine Chloride Stored in Room-Temperature Syringes
D.P. Culp Center Ballroom
Introduction: Succinylcholine chloride is a compound commonly used for neuromuscular blockade for endotracheal intubation, surgery or mechanical ventilation. Typically, the 20mg/mL vials are able to be stored in refrigeration at 2° to 8°C (36° to 46°F) or up to 14 days at room temperature without significant loss of potency, as per the manufacturer’s labeling. Data available on stability ranges from days to months, with some suggesting demonstrated stability at ~6 months in unrefrigerated unopened vials at room temperature and 45 days for syringes prepared onsite (20mg/mL in polypropylene) stored at room temperature. In this study, we will investigate the stability of succinylcholine chloride stored in 1mL aliquots in room temperature syringes. The ability to pre-fill syringes and store at room temperature facilitates timely dosing and may help mitigate dosing errors that could incur when pulling drug product from the bulk container. Methods: In order to investigate drug stability, a quantitative high-performance liquid chromatography (HPLC) method must be developed and validated. The validation for our HPLC method with ultraviolet detection (UV) involved investigation of system suitability, accuracy, precision, and linearity. USP guidelines were used as determining validity of the parameters tested including >2000 theoretical plates, <2 Tailing>Factor, <5% Relative Standard Deviation (RSD), and <5% Error across 3 days. Mobile phases included a 0.01% trifluoracetic acid buffer in water (A) and 100% acetonitrile (B). A Waters XBridge C18 column (4.6 x 150 mm, 3.5 micron) was used for an isocratic separation of 60% A and 40% B. The flow rate was maintained at 0.4 mL/min, and the column oven at 30oC. The UV detector wavelength was set to 218nm. Stability analysis will be carried out using 10 vials of 20mg/mL succinylcholine chloride (Manufacturer). There will be 5 vials left as controls and 5 vials drawn into syringes (1mL aliquots) and assay tested at different timepoints over 30 days. Sampling days will include time 0hrs, 24hrs, 48hrs, 72hrs, 7 days, 10 days, 14 days, 21 days, and 30 days. Recovery of succinylcholine will be compared between drug stored in syringes versus the manufacturer’s container. Results: After validation analysis, the accuracy determination produced a % error of 0.54%, 0.17%, and 2.39% for concentrations at 125%, 100%, and 75% respectively. Precision analysis of the data produced an RSD of 2.48%, 4.07%, and 2.51% respectively for concentrations at 125%, 100%, and 75% (Spec NMT 5%). Combined linearity produced a result of R^2 = 0.9991, with a calibration range of 5, 10, 15, 20 and 25 mg/mL. Conclusion: The HPLC-UV method tested achieved precise and accurate results and meets USP criteria for system suitability. Furthermore, it generates linear data within the calibration range of this study. This method will be a useful tool in the investigation of succinyl choline chemical potency over different timepoints in a 30-day period.