Fluoxetine伏安定量法應用於血管及品保程序   全文下載

Voltammetric Quantification of Fluoxetine: Application to Quality Control and Quality Assurance Processes

以玻璃碳電極在不同緩衝系統及不同pH下用環狀伏安法、微分脈衝伏安法及方波伏安法分析之fluoxetine的氧化模式已被研究。利用pH9硼酸緩衝溶液當作電解質，一項適合fluoxetine商業化生產品管之新方波伏安法已被開發。在最適條件下，10 ~ 16μM濃度範圍內為線性，檢測極限為1.0μM。確認參數，如敏感性、精確性及準確性亦被評估。這項方法已成功地應用在fluoxetine製程。結果與HPLC法相較是令人滿意的。這些方法之間無顯著差異。

The oxidative behaviour of fluoxetine was studied at a glassy carbon electrode in various buffer systems and at different pH using cyclic, differential pulse and square wave voltammetry. A new square wave voltammetric method suitable for the quality control of fluoxetine in commercial formulations has been developed using a borate pH 9 buffer solution as supporting electrolyte. Under optimized conditions, a linear response was obtained in the range 10 to 16 μM with a detection limit of 1.0 μM. Validation parameters such as sensitivity, precision and accuracy were evaluated. The proposed method was successfully applied to the determination of fluoxetine in pharmaceutical formulations. The results were statistically compared with those obtained by the reference high-performance liquid chromatographic method. No significant differences were found between the methods.