title: Stability of fluoxetine hydrochloride in fluoxetine solution diluted with common pharmaceutical diluents.
abstract: The stability of fluoxetine hydrochloride in fluoxetine solution diluted with five common pharmaceutical diluents was studied. Fluoxetine syrup, containing fluoxetine 4 mg/mL (as the hydrochloride salt), was diluted to 1 and 2 mg/mL in each of the following: deionized water; Simple Syrup, British Pharmacopeia; Simple Syrup, USP; Aromatic Elixir, USP; and grape-cranberry drink. Each solution was divided into eight 120-mL amber glass bottles: four stored at 5 degrees C and four stored at 30 degrees C. Samples were removed from each bottle at time zero and two, four, and eight weeks and assayed in triplicate with high-performance liquid chromatographic methods for determining fluoxetine concentration and concentration of its primary degradation product, alpha-[2-(methylamino)ethyl]benzene methanol. Stability was established if the fluoxetine concentration changed by < 10% and if the concentration of the degradation product was < 1% of the initial fluoxetine concentration. No test mixture dropped below 95% of the initial fluoxetine concentration or exceeded 0.5% degradation product during the study period. Fluoxetine hydrochloride was stable for eight weeks in fluoxetine solution diluted to 1 or 2 mg/mL with common pharmaceutical diluents and stored at 5 or 30 degrees C.
authors.affiliation: Pharmaceutical Sciences Division, Eli Lilly and Company, Indianapolis, IN 46285.
authors.forename: J A
authors.initials: JA
authors.lastname: Peterson
authors.forename: D S
authors.initials: DS
authors.lastname: Risley
authors.forename: P N
authors.initials: PN
authors.lastname: Anderson
authors.forename: K F
authors.initials: KF
authors.lastname: Hostettler
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D005473:Fluoxetine / Q000737:chemistry*; D006801:Humans; D014677:Pharmaceutical Vehicles / Q000737:chemistry; D012996:Solutions / Q000737:chemistry
chemical_list: D014677:Pharmaceutical Vehicles; D012996:Solutions; D005473:Fluoxetine