title: Stability of propafenone hydrochloride in i.v. solutions.
abstract: The stability of propafenone hydrochloride in i.v. solutions was studied. Solutions of propafenone hydrochloride 2, 1, and 0.5 mg/mL in 5% dextrose injection and in 5% dextrose and 0.2% sodium chloride injection were prepared. Portions of each type of solution were transferred to 10-mL polypropylene syringes and to 150-mL polyvinyl chloride (PVC) bags. Syringes and bags were stored at 20.5-22.5 degrees C under fluorescent light. Two 0.5-mL samples were drawn from each container at 0, 6, 12, 24, 36, and 48 hours and frozen in polystyrene tubes at -20 degrees C until assayed. Propafenone concentrations were determined by high-performance liquid chromatography. All samples of propafenone hydrochloride 2 mg/mL in 5% dextrose and 0.2% sodium chloride injection taken from PVC bags precipitated when thawed. For the remaining solutions, the mean decrease from the initial concentration was < 10% regardless of diluent, container type, and initial concentration. Propafenone hydrochloride 1 and 0.5 mg/mL in 5% dextrose injection or in 5% dextrose and 0.2% sodium chloride injection was stable for 48 hours at 20.5-22.5 degrees C when stored in polypropylene syringes or PVC bags. Propafenone hydrochloride 2 mg/mL in 5% dextrose injection was stable for 48 hours when stored in syringes or bags, but in 5% dextrose and 0.2% sodium chloride injection was stable in syringes only.
authors.affiliation: Department of Pharmacy, Hospital for Sick Children, Toronto, Ontario, Canada. lee.dupuis@mailhub.sickkids.on.ca
authors.forename: L L
authors.initials: LL
authors.lastname: Dupuis
authors.forename: B
authors.initials: B
authors.lastname: Wong
authors.forename: A
authors.initials: A
authors.lastname: Trope
mesh_terms: D000889:Anti-Arrhythmia Agents / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D003422:Critical Care; D004355:Drug Stability; D004356:Drug Storage; D005947:Glucose; D006801:Humans; D007275:Injections, Intravenous; D011126:Polypropylenes; D011145:Polyvinyls; D011405:Propafenone / Q000737:chemistry*; D012965:Sodium Chloride; D012996:Solutions
chemical_list: D000889:Anti-Arrhythmia Agents; D011126:Polypropylenes; D011145:Polyvinyls; D012996:Solutions; D012965:Sodium Chloride; D011405:Propafenone; D005947:Glucose