萃取分光光度法測定 cetirizine dihydrochloride 純品及其製劑   全文下載

Extractive Spectrophotometric Determination of Cetirizine Dihydrochloride in Pure and Pharmaceutical Preparations

簡單且靈敏度高之萃取分光光度法測定cetirizine dihydrochloride純品與各種製劑。此方法係奠基於cetirizine dihydrochloride與甲基橙在酸性環境中（pH 4.0）反應，再經氯仿萃取後，會形成最大吸光度424.5 nm之黃色離子對化合物。在2.5-20 μg/mL濃度範圍內，本方法符合比爾定律，實驗依據國際醫藥法規協和會指引，就各種變數進行測試及確效，定量及偵測極限分別為 1.0 及3.0 μg/mL，能成功地應用於cetirizine dihydrochloride製劑測定。結果顯示，本方法精準、明確且具再現性（相對標準偏差< 1.13%），統計分析顯示，與參考方法之結果沒有顯著差異，製劑亦未發現干擾物質。

A simple and sensitive extractive spectrophotometric method has been described for the assay of cetirizine dihydrochloride in pure and different pharmaceutical preparations. The method was based on the formation of the ion-pair complex from the reaction between cetirizine dihydrochloride and methyl orange in pH 4.0, which gave a yellow color after chloroform extraction and exhib-ited a maximum absorbance at 424.5 nm. Beer's law was obeyed in the concentration range of 2.5 - 20 μg/mL. The method was tested and validated for various parameters according to ICH guidelines. The detection and quantification limits were 1.0 and 3.0 μg/mL, respectively. The proposed method was successfully applied for the determination of cetirizine dihydrochloride in phar-maceutical preparations. The results demonstrated that the procedure was accurate, precise and reproducible while statistical anal-ysis of the obtained results showed no significant difference between the proposed method and reference method. No interference was observed for common pharmaceutical preparations.