title: Long-term stability of dexamethasone and alizapride or ondansetron in sodium chloride 0.9% polyolefin bag at 5±3°C.
abstract: BACKGROUND
  The aim of the study was to investigate the long-term stability of dexamethasone 10mg associated with alizapride 100mg or ondansetron 8mg in 100mL of 0.9% sodium chloride solution stored at 5±3°C.
  
  
  METHODS
  Solutions of 0.9% sodium chloride 100mL in polyolefin bags (n=5) containing approximately dexamethasone (DEX) 10mg associated with alizapride (ALI) 100mg or ondansetron (OND) 8mg were prepared under aseptic conditions and stored about 30 days at 5±3°C. ALI, DEX and OND concentrations were measured by high-performance liquid chromatography (HPLC). Optic density measurement at different wavelengths, pH measurement and optic microscope observations were performed periodically during the storage. A forced degradation test with HCL 5M and NaOH 5M before and after heating at 100°C was also performed. Solutions were considered stable if the 95% one-sided lower confidence limit of the concentration remains superior to 90% of the initial concentration or 95% of the initial concentration when any signs of physical instability exist as recently recommend.
  
  
  RESULTS
  The calibration was linear over the following range from 20 to 1.25mg/100mL for DEX, from 200 to 12.5mg/100mL for ALI and from 20 to 1.25mg/100mL for OND with a calculated correlation coefficient (r2) of 0.998, 0.999 and 0.999, respectively. The inter- and intra-assay precision was below 10% for both mixtures. All formulations 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 30 days.
  
  
  CONCLUSIONS
  The HPLC method is specific and reproducible and can easily be adopted for monitoring the quality control in the production of DEX-ALI and DEX-OND bags. Solutions of DEX-ALI and DEX-OND were physically and chemically stable for 30 days in polyolefin bags stored at 5±3°C and could therefore be prepared in advance.
authors.affiliation: Medical Laboratory, CHU UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
authors.forename: J
authors.initials: J
authors.lastname: Simar
authors.affiliation: Medical Laboratory, CHU UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium; Drug Stability Research Group, CHU UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Godet
authors.affiliation: Department of Pharmacy, CHU UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium; Drug Stability Research Group, CHU UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium. Electronic address: jean-daniel.hecq@uclouvain.be.
authors.forename: J-D
authors.initials: JD
authors.lastname: Hecq
authors.affiliation: Medical Laboratory, CHU UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Closset
authors.affiliation: Department of Pharmacy, CHU UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
authors.forename: P
authors.initials: P
authors.lastname: Gillet
authors.affiliation: Department of Pharmacy, CHU UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
authors.forename: C
authors.initials: C
authors.lastname: Langhendries
authors.affiliation: Scientific Support Unit, CHU UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
authors.forename: B
authors.initials: B
authors.lastname: Bihin
authors.affiliation: Scientific Support Unit, CHU UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
authors.forename: J
authors.initials: J
authors.lastname: Jamart
authors.affiliation: Medical Laboratory, CHU UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium; Drug Stability Research Group, CHU UCL Namur, 1, avenue Therasse, 5530 Yvoir, Belgium.
authors.forename: L
authors.initials: L
authors.lastname: Galanti
mesh_terms: D000932:Antiemetics / Q000032:analysis*; D003907:Dexamethasone / Q000032:analysis*; D004338:Drug Combinations; D004355:Drug Stability; D004356:Drug Storage; D017294:Ondansetron / Q000032:analysis*; D019999:Pharmaceutical Solutions; D011090:Polyenes; D011759:Pyrrolidines / Q000032:analysis*; D012965:Sodium Chloride
chemical_list: D000932:Antiemetics; D004338:Drug Combinations; D019999:Pharmaceutical Solutions; D011090:Polyenes; D011759:Pyrrolidines; D012965:Sodium Chloride; D017294:Ondansetron; D003907:Dexamethasone; C035051:PL 732; C033968:alizapride
keywords: Alizapride; CIVA; CLHP; Dexamethasone; Dexaméthasone; Drug stability; HPLC; Ondansetron; Stabilité chimique; Unité centrale de reconstitution d’injectables