Peterson J A, Risley D S, Anderson P N, Hostettler K F
Pharmaceutical Sciences Division, Eli Lilly and Company, Indianapolis, IN 46285.
Am J Hosp Pharm. 1994 May 15;51(10):1342-5.
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.
研究了盐酸氟西汀在五种常用药用稀释剂稀释的氟西汀溶液中的稳定性。将含4 mg/mL氟西汀（盐酸盐形式）的氟西汀糖浆分别用以下物质稀释至1 mg/mL和2 mg/mL：去离子水；英国药典规定的单糖浆；美国药典规定的单糖浆；美国药典规定的芳香酏剂；葡萄酸果蔓饮料。每种溶液均分成八个120 mL的琥珀色玻璃瓶：四个在5℃储存，四个在30℃储存。在零周、两周、四周和八周时从每个瓶子中取出样品，用高效液相色谱法一式三份测定氟西汀浓度及其主要降解产物α-[2-(甲氨基)乙基]苯甲醇的浓度。如果氟西汀浓度变化<10%，且降解产物浓度<初始氟西汀浓度的1%，则判定为稳定。在研究期间，没有测试混合物的氟西汀浓度降至初始浓度的95%以下或降解产物超过0.5%。盐酸氟西汀在与常用药用稀释剂稀释至1或2 mg/mL并储存在5或30℃的氟西汀溶液中稳定八周。
