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新型电位测定法在泮托拉唑钠和伊托必利盐酸盐的纯品及复方制剂中的应用。

Novel potentiometric application for the determination of pantoprazole sodium and itopride hydrochloride in their pure and combined dosage form.

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., ET-11562 Cairo, Egypt.

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., ET-11562 Cairo, Egypt.

出版信息

Talanta. 2015 Jun 1;138:28-35. doi: 10.1016/j.talanta.2015.01.045. Epub 2015 Feb 9.

DOI:10.1016/j.talanta.2015.01.045
PMID:25863367
Abstract

Three sensitive and selective polyvinyl chloride (PVC) matrix membrane electrodes were developed and investigated. Sensor I was developed using tetraheptylammonium bromide (THB) as an anion exchanger with 2-nitrophenyl octyl ether (2-NPOE) as a plasticizer for the determination of the anionic drug pantoprazole sodium sesquihydrate (PAN). To determine the cationic drug itopride hydrochloride (ITH), two electrodes (sensors II and III) were developed using potassium tetrakis(4-chlorophenyl) borate (KTCPB) as a cation exchanger with dioctyl phthalate (DOP) as a plasticizer. Selective molecular recognition components, 2-hydroxypropyl-β-cyclodextrin (2-HP βCD) and 4-tert-butylcalix[8]arene (tBC8), were used as ionophores to improve the selectivity of sensors II and III, respectively. The proposed sensors had a linear dynamic range of 1×10(-5) to 1×10(-2) mol L(-1) with Nernstian slopes of -54.83±0.451, 56.90±0.300, and 51.03±1.909 mV/decade for sensors I, II and III, respectively. The Nernstian slopes were also estimated over the pH ranges of 11-13, 3.5-8 and 4-7 for the three sensors, respectively. The proposed sensors displayed useful analytical characteristics for the determination of PAN and ITH in bulk powder, in laboratory prepared mixtures and in combined dosage forms with clear discrimination from several ions, sugars and some common drug excipients. The method was validated according to ICH guidelines. Statistical comparison between the results from the proposed method and the results from the reference methods showed no significant difference regarding accuracy and precision.

摘要

研制并研究了三种灵敏且选择性的聚氯乙烯(PVC)基质膜电极。传感器 I 是使用四庚基溴化铵(THB)作为阴离子交换剂,以 2-硝基辛基醚(2-NPOE)作为增塑剂,用于测定阴离子药物泮托拉唑钠半水合物(PAN)。为了测定阳离子药物伊托必利盐酸盐(ITH),使用四(对氯苯基)硼酸钾(KTCPB)作为阳离子交换剂,邻苯二甲酸二辛酯(DOP)作为增塑剂,研制了两个电极(传感器 II 和 III)。选择分子识别成分 2-羟丙基-β-环糊精(2-HP βCD)和 4-叔丁基杯[8]芳烃(tBC8)分别作为离子载体,以提高传感器 II 和 III 的选择性。所提出的传感器的线性动态范围为 1×10(-5)至 1×10(-2) mol L(-1),具有 Nernst 斜率为-54.83±0.451、56.90±0.300 和 51.03±1.909 mV/decade,分别用于传感器 I、II 和 III。三个传感器的 Nernst 斜率也分别在 pH 值范围为 11-13、3.5-8 和 4-7 时进行了估算。所提出的传感器在散装粉末、实验室制备混合物以及与几种离子、糖和一些常见药物赋形剂的组合剂型中具有有用的分析特性,可进行明确的区分。该方法根据 ICH 指南进行了验证。根据准确度和精密度,对所提出的方法和参考方法的结果进行了统计比较,结果无显著差异。

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