以分光光度計法檢測散裝及藥品賦形劑中的Ritodrine   全文下載

Spectrophotometric Methods for Determination of Ritodrine in Bulk and in Pharmaceutical Dosage Forms

三種簡單、靈敏的分光光度計法於本文中被論述，用以檢測純態或劑形中的ritodrine hydrochloride（RTH）。第一種方法是根據4-chloro-7-nitrobenzo-2-oxa-1,3-diazole（NBD-Cl）在pH 8.0 的硼酸緩衝溶液產生黃色產物反應，其檢測波長為392 nm。第二種及第三種方法是根據RTH 分別與1,10-phenanthroline 或Folin-Ciocalteu 試劑發生氧化作用而產生紅色或藍色色原，其檢測波長分別為510 及760 nm。此三種方法的最低檢測值分別為0.1、0.05 及0.14 μg/mL，符合比爾定律的濃度範圍分別為2-16、0.2-2 及0.8-12 μg/mL。影響有色物質形成與穩定的不同實驗參數已被詳加研究及最適化。不同外來物質及致敏物質對於三種方法成色之影響亦被研究。這些提出的方法已成功地應用在劑形中RTH 的檢測。所得到的平均回收率（%）分別為99.73 ± 0.72、99.88 ± 1.2 及99.97 ± 0.42。所得結果進行統計確效，並與參考方法所得之結果比較。另外，反應機構的資料亦被提出。"

Three simple and sensitive spectrophotometric methods are described for determination of ritodrine hydrochloride (RTH) either in pure form or dosage forms. The first method was based on the reaction with 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole (NBD-Cl) in borate buffer of pH 8.0 producing a yellow colored product measured at 392 nm. The second and third methods were based on RTH oxidation with either 1,10-phenanthroline or Folin-Ciocalteu reagents producing red and blue chromogens which were measured at 510 and 760 nm, respectively. Beer’s law was obeyed in the ranges of, 2-16, 0.2-2, 0.8-12 μg/mL with the minimum detectable values of 0.1, 0.05, 0.14 μg/mL for the three methods, respectively. Different experimental parameters affecting the development and stability of colored products were carefully studied and optimized. The effect of different foreign matters and sensitizers on the color development in the three proposed methods was also studied. The proposed methods were successfully applied to the determination of RTH in its dosage forms. The obtained percentage recoveries were 99.73 ± 0.72, 99.88 ± 1.2, 99.97 ± 0.42 for the three proposed methods, respectively. The obtained results were statistically validated and compared with those obtained with a reference method. Proposals of the reactions mechanisms were presented.