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非那西丁在纯品、制剂和生物体液中的溶解试验和电位测定。

Dissolution testing and potentiometric determination of famciclovir in pure, dosage forms and biological fluids.

机构信息

Faculty of Pharmacy and Biotechnology, Pharmaceutical Chemistry Department, German University in Cairo, New Cairo City, Egypt.

出版信息

Bioelectrochemistry. 2013 Feb;89:26-33. doi: 10.1016/j.bioelechem.2012.08.006. Epub 2012 Sep 5.

Abstract

The performance characteristics of two new plastic membrane ion selective electrodes (ISEs) used for the determination of famciclovir (Fcv) based on the ion associate of Fcv with phosphotungstic acid (PTA) or phosphomolybdic acid (PMA) are described. Different experimental conditions as type of plasticizer to be incorporated in the membrane, life span, effect of soaking, pH, temperature, and interferences were studied. Both electrodes showed similar performance under these conditions, exhibiting Nernstian slopes of S (Fcv-PTA)=58.60±0.84 mV/decade and S (Fcv-PMA)=58.77±0.68 mV/decade within a usable concentration range of 10⁻⁵-10⁻² [Fcv/M] at 298/K. Famciclovir was assayed potentiometrically in its pure solution, pharmaceutical preparations and biological fluids (urine and plasma) using proposed electrodes under batch and flow injection analysis (FIA) conditions with a recovery % ranging between 96.76% and 102.83% having RSD of 0.66%-1.81%. The electrodes were also successfully applied in the determination of the dissolution profile of Fcv tablets and the results came in agreement with the validated results of the HPLC method obtained from the quality control unit of the company producing the tablets.

摘要

描述了两种新型塑料膜离子选择性电极(ISE)用于测定法昔洛韦(Fcv)的性能特征,该测定基于 Fcv 与磷钨酸(PTA)或磷钼酸(PMA)的离子缔合物。研究了不同的实验条件,如要掺入膜中的增塑剂类型、寿命、浸泡效应、pH 值、温度和干扰。在这些条件下,两个电极都表现出相似的性能,在 298/K 下,Fcv-PTA 的 Nernst 斜率为 S(Fcv-PTA)=58.60±0.84 mV/decade,Fcv-PMA 的 Nernst 斜率为 S(Fcv-PMA)=58.77±0.68 mV/decade,在 10⁻⁵-10⁻² [Fcv/M] 的可用浓度范围内。使用提议的电极,在批处理和流动注射分析(FIA)条件下,在纯溶液、药物制剂和生物流体(尿液和血浆)中测定法昔洛韦的含量,回收率在 96.76%至 102.83%之间,相对标准偏差(RSD)在 0.66%-1.81%之间。这些电极还成功地应用于测定 Fcv 片剂的溶解曲线,结果与公司质量控制部门获得的 HPLC 方法的验证结果一致。

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