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使用聚合物膜电极选择性电位法测定片剂和生物流体中的半酒石酸唑吡坦。

Selective potentiometric determination of zolpidem hemitartrate in tablets and biological fluids by using polymeric membrane electrodes.

作者信息

Kelani Khadiga M

机构信息

Cairo University, Faculty of Pharmacy, Department of Analytical Chemistry, Cairo, Egypt.

出版信息

J AOAC Int. 2004 Nov-Dec;87(6):1309-18.

Abstract

The construction and electrochemical response characteristics of 4 polymeric membrane sensors were investigated for potentiometric determination of zolpidem hemitartrate. The construction of the 4 sensors was based on the formation of ion-pair complexes between the drug cation and ionic sites in the ratio of 1:2, respectively. Two of the sensors were constructed by using ammonium reineckate or ammonium tungstate as the fixed ionic site in a polymeric matrix of polyvinyl chloride (PVC) (sensors 1 and 2). Linear responses over the concentration range of 10(-5)-10(-3)M, with cationic slopes of 30 and 30.7 mV per concentration decade, were obtained by using sensors 1 and 2, respectively. The third sensor was fabricated by using PVC carboxylate (PVC-COOH). The dissociated COOH groups in the PVC-COOH act as a mediator and/or ionic site. A linear response was obtained over the concentration range of 10(-5)-10(-2)M with a cationic slope of 29 mV per concentration decade. Sensor 4 was fabricated by using 2,6-didodecyl-beta-cyclodextrin as the ionophore, polyurethane (Tecoflex) as a polymeric matrix, and potassium tetraphenyl borate as the ionic site; it showed a linear response over the concentration range of 10(-7)-10(-2)M with a cationic slope of 28.9 mV per concentration decade. The direct potentiometric determination of zolpidem hemitartrate in pure forms by using the 4 proposed sensors gave average recoveries of 98.5+/-0.7, 99.4 +/-0.2, 100.7+/-0.10, and 99.8+/-0.1% for sensors 1-4, respectively. The results obtained by the proposed procedures were statistically analyzed and compared with those obtained by using a reported method. The 4 proposed sensors were also applied successfully to the determination of the drug in tablets and in biological fluids. Average recoveries obtained by using sensors 1, 2, 3, and 4 for drug assay of tablets were 99.6+/-0.6, 100+/-0.7, 99.7+/-0.4, and 99.5+/-0.8%, respectively. The presence of tablet excipients did not interfere with the determination of the drug or with the accuracy and precision of the 4 proposed methods. The methods were also used to determine the drug in the presence of its degradates and thus could be used as stability-indicating methods.

摘要

研究了4种聚合物膜传感器的构建及其电化学响应特性,用于电位法测定半酒石酸唑吡坦。这4种传感器的构建基于药物阳离子与离子位点以1:2的比例形成离子对络合物。其中两种传感器是通过使用雷氏铵盐或钨酸铵作为聚氯乙烯(PVC)聚合物基质中的固定离子位点构建的(传感器1和2)。使用传感器1和2分别在10(-5)-10(-3)M的浓度范围内获得了线性响应,阳离子斜率分别为每浓度 decade 30和30.7 mV。第三种传感器是通过使用PVC羧酸盐(PVC-COOH)制造的。PVC-COOH中解离的COOH基团充当介质和/或离子位点。在10(-5)-10(-2)M的浓度范围内获得了线性响应,阳离子斜率为每浓度 decade 29 mV。传感器4是通过使用2,6-二十二烷基-β-环糊精作为离子载体、聚氨酯(Tecoflex)作为聚合物基质以及四苯硼酸钾作为离子位点制造的;它在10(-7)-10(-2)M的浓度范围内显示出线性响应,阳离子斜率为每浓度 decade 28.9 mV。使用所提出的4种传感器对纯形式的半酒石酸唑吡坦进行直接电位测定,传感器1-4的平均回收率分别为98.5±0.7%、99.4±0.2%、100.7±0.10%和99.8±0.1%。对所提出方法获得的结果进行了统计分析,并与使用报道方法获得的结果进行了比较。所提出的4种传感器还成功应用于片剂和生物流体中药物的测定。使用传感器1、2、3和4进行片剂药物测定的平均回收率分别为99.6±0.6%、100±0.7%、99.7±0.4%和99.5±0.8%。片剂辅料的存在不干扰药物的测定,也不干扰所提出的4种方法的准确性和精密度。这些方法还用于在药物降解产物存在的情况下测定药物,因此可作为稳定性指示方法。

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