螢光分析法測定非類固醇消炎藥 Etodolac 和 Diclofenac Sodium 製劑   全文下載

New and Sensitive Spectrofluorimetric Method for the Determination of Non-Steroidal Anti inflammatory Drugs, Etodolac and Diclofenac Sodium in Pharmaceutical Preparations through Derivatization with 7-fluoro-4-nitrobenzo-2-oxa-1,3-diazole

開發並確效一種快速，準確且靈敏的檢驗方法測定非類固醇消炎藥Etodolac和Diclofenac Sodium製劑。本方法是基於此二藥物在緩衝液pH值8.5時，與7-fluoro-4-nitrobenzo-2-oxa-1,3-diazole（nBD-F）反應，會有黃色螢光物產生。本方法經特異性，線性，偵測極限，定量極限，精密度，準確度，回收率和穩定性等確效。Etodolac濃度範圍40 - 600 ng/mL， Diclofenac Sodium濃度範圍25 - 500 ng/mL時，符合比爾定律（Beer’s law）。Etodolac和Diclofenac Sodium的偵測極限分別為 0.071 ng/mL及0.055 ng/mL。檢驗結果之統計分析顯示本方法具高準確性與精密度，可成功應用於測定藥物製劑且回收率佳。本方法靈敏、準確、簡單，檢驗結果與公定檢驗方法（official method）相當。"

A rapid, accurate and sensitive method was developed and validated for the determination of non-steroidal anti-inflamma-tory drugs, etodolac and diclofenac sodium in pharmaceutical preparations. The proposed method was based on the reaction of these drugs with 7-fluoro-4-nitrobenzo-2-oxa-1,3-diazole (NBD-F) in buffer of pH 8.5 to yield a yellow, fluorescent product. The method was validated for specificity, linearity, limit of detection, limit of quantification, precision, accuracy, recovery and robust-ness. Beer’s law is obeyed over the concentration range of 40 - 600 ng/mL for etodolac, 25 - 500 ng/mL for diclofenac sodium, respectively. The detection limits were found to be 0.071 ng/mL for etodolac, 0.055 ng/mL for diclofenac sodium, respectively. Statistical analysis of the results has been carried out revealing high accuracy and good precision. The proposed methods were successfully applied for the determination of the drugs in their pharmaceutical preparations with good recoveries. The developed methods were sensitive, accurate and simple. The results obtained by the proposed method were comparable with those obtained by the official method.