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伪麻黄碱与不同无机和有机试剂反应的分光光度研究及其在纯品和制剂中的微量测定。

Spectrophotometric studies of reactions between pseudo-ephedrine with different inorganic and organic reagents and its micro-determination in pure and in pharmaceutical preparations.

机构信息

Chemistry Department, Faculty of Science, Cairo University, Giza, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2012 Mar;88:156-61. doi: 10.1016/j.saa.2011.12.022. Epub 2011 Dec 22.

DOI:10.1016/j.saa.2011.12.022
PMID:22226899
Abstract

Two simple, sensitive, cheep and reliable spectrophotometric methods are suggested for micro-determination of pseudoephedrine in its pure form and in pharmaceutical preparation (Sinofree Tablets). The first one depends on the drug reaction with inorganic sensitive reagent like molybdate anion in aqueous media via formation of ion-pair mechanism. The second one depends on the drug reaction with π-acceptor reagent like DDQ in non-aqueous media via formation of charge transfer complex. These reactions were studied under various conditions and the optimum parameters were selected. Under proper conditions the suggested procedures were successfully applied for micro-determination of pseudoephedrine in pure and in Sinofree Tablets without interference from excepients. The values of SD, RSD, recovery %, LOD, LOQ and Sandell sensitivity refer to the high accuracy and precession of the applied procedures. The results obtained were compared with the data obtained by an official method, referring to confidence and agreement with DDQ procedure results; but it referred to the more accuracy of the molybdate data. Therefore, the suggested procedures are now successfully being applied in routine analysis of this drug in its pharmaceutical formulation (Sinofree) in Saudi Arabian Pharmaceutical Company (SPIMACO) in Boridah El-Qaseem, Saudi Arabia instead of imported kits had been previously used.

摘要

两种简单、灵敏、廉价且可靠的分光光度法被建议用于伪麻黄碱纯品和药物制剂(新福泰片)的微量测定。第一种方法依赖于药物与无机敏化试剂(如水相中的钼酸盐阴离子)通过离子对机制反应。第二种方法依赖于药物与π-受体试剂(如非水相中的 DDQ)反应,通过形成电荷转移络合物。在各种条件下研究了这些反应,并选择了最佳参数。在适当的条件下,所提出的方法成功地应用于伪麻黄碱的微量测定,无需干扰赋形剂。SD、RSD、回收率%、LOD、LOQ 和桑德尔灵敏度的值表明应用程序具有高精度和精密性。所得结果与官方方法获得的数据进行了比较,这表明与 DDQ 程序结果具有可信度和一致性;但钼酸盐数据的准确性更高。因此,所提出的方法现已成功应用于沙特阿拉伯 Boridah El-Qaseem 的沙特制药公司(SPIMACO)中该药物及其药物制剂(新福泰)的常规分析,而不是以前使用的进口试剂盒。

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