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使用智能分光光度法同时测定止咳制剂中马来酸氯苯那敏、福尔可定和盐酸麻黄碱且不受色素干扰的新方法。

Novel Approach for the Simultaneous Determination of Carbinoxamine Maleate, Pholcodine, and Ephedrine Hydrochloride Without Interference from Coloring Matter in an Antitussive Preparation Using Smart Spectrophotometric Methods.

作者信息

Moustafa Azza A, Hegazy Maha A, Mohamed Dalia, Ali Omnia

机构信息

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

October University for Modern Sciences and Arts, Faculty of Pharmacy, Analytical Chemistry Department, 11787 6th of October City, Egypt Helwan University, Faculty of Pharmacy, Analytical Chemistry Department, Ein Helwan, 11795 Cairo, Egypt.

出版信息

J AOAC Int. 2018 Mar 1;101(2):414-426. doi: 10.5740/jaoacint.17-0078. Epub 2017 Aug 1.

DOI:10.5740/jaoacint.17-0078
PMID:28766478
Abstract

The presence of coloring matters in syrups usually interferes with the spectrophotometric determination of active pharmaceutical ingredients. A novel approach was introduced to eliminate the interference of sunset yellow (coloring matter) in Cyrinol syrup. Smart, simple, accurate, and selective spectrophotometric methods were developed and validated for the simultaneous determination of a ternary mixture of carbinoxamine maleate, pholcodine, and ephedrine hydrochloride in syrup. Four of the applied methods used ratio spectra: successive derivative subtraction coupled with constant multiplication, successive derivative of ratio spectra, ratio subtraction coupled with ratio difference, and ratio spectra continuous wavelet transforms zero-crossing. In addition, a method that was based on the presence of an isosbestic point, the amplitude summation method, was also established. A major advantage of the proposed methods is the simultaneous determination of the mentioned drugs without prior separation steps. These methods were successfully applied for the determination of laboratory-prepared mixtures and a commercial pharmaceutical preparation without interference from additives, thus proving the selectivity of the methods. No significant difference regarding both accuracy and precision was observed upon statistical comparison of the results obtained by the proposed methods with each other and with those of official or reported ones.

摘要

糖浆中色素的存在通常会干扰活性药物成分的分光光度法测定。引入了一种新方法来消除西瑞诺糖浆中日落黄(色素)的干扰。开发并验证了智能、简单、准确且选择性的分光光度法,用于同时测定糖浆中马来酸氯苯那敏、福尔可定和盐酸麻黄碱的三元混合物。所应用的方法中有四种使用了比率光谱:连续导数减法结合常数乘法、比率光谱的连续导数、比率减法结合比率差以及比率光谱连续小波变换零交叉。此外,还建立了一种基于等吸收点存在的方法,即振幅求和法。所提出方法的一个主要优点是无需事先分离步骤即可同时测定上述药物。这些方法已成功应用于测定实验室制备的混合物和市售药物制剂,不受添加剂干扰,从而证明了方法的选择性。将所提出方法获得的结果相互之间以及与官方或报道方法的结果进行统计比较时,在准确性和精密度方面均未观察到显著差异。

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