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基于相邻数据点差异的新型化学计量学模式用于同时测定氯吡格雷、阿托伐他汀和阿司匹林三联复方制剂中的含量

New Chemometrics Mode Based on Adjacent Data Points' Differences for the Simultaneous Determination of Clopidogrel, Atorvastatin, and Aspirin in their Combined Ternary Drug Formulation.

作者信息

Nejem R'afat Mahmoud, Issa Mahmoud Mohamed, Shanab Alaa Abu, Stefan-Van Staden Raluca-Ioana, Aboul-Enein Hassan Y

机构信息

Analytical Chemistry, Department of Chemistry, Alaqsa University, P.O.Box 4051, Gaza, Palestine.

Pharmaceutical Analytical Chemistry, Department of Chemistry, Alaqsa University, P.O.Box 4051, Gaza, Palestine.

出版信息

Sci Pharm. 2014 Mar 24;82(3):601-15. doi: 10.3797/scipharm.1401-21. Print 2014 Jul-Sep.

Abstract

A new method is proposed for the analysis of a ternary mixture composed of clopidogrel, atorvastatin, and aspirin without prior separation steps. The method combines the advantages of the mean centering of ratio spectra and derivative spectrophotometric methods. It is based on using the difference between adjacent data points in the absorbance spectra. The principal advantage of this method is the use of absorbance data, and not derivative data; hence the signal-to-noise ratio is not diminished. The mathematical explanation of the procedure is illustrated. Beer's law was valid in the concentration range 0.3-35 μg.mL(-1) for CLOP, 0.5-30 μg.mL(-1) for ATOR, and 1-40 μg.mL(-1) for ASP. Mean recoveries were obtained as 100.2, 100.1, and 100.2% for CLOP, ATOR, and ASP, respectively, in the prepared synthetic mixtures. The method has been successfully applied to the simultaneous determination of ternary mixtures of aspirin, clopidogrel bisulphate, and atorvastatin calcium. The analytical characteristics of the method were calculated. The results showed that the new method is simple, rapid, accurate, and precise.

摘要

提出了一种无需预先分离步骤即可分析由氯吡格雷、阿托伐他汀和阿司匹林组成的三元混合物的新方法。该方法结合了比率光谱均值中心化和导数分光光度法的优点。它基于使用吸光度光谱中相邻数据点之间的差异。该方法的主要优点是使用吸光度数据而非导数数据;因此信噪比不会降低。文中说明了该程序的数学解释。对于氯吡格雷,比尔定律在0.3 - 35 μg·mL⁻¹的浓度范围内有效;对于阿托伐他汀,在0.5 - 30 μg·mL⁻¹范围内有效;对于阿司匹林,在1 - 40 μg·mL⁻¹范围内有效。在所制备的合成混合物中,氯吡格雷、阿托伐他汀和阿司匹林的平均回收率分别为100.2%、100.1%和100.2%。该方法已成功应用于阿司匹林、硫酸氢氯吡格雷和阿托伐他汀钙三元混合物的同时测定。计算了该方法的分析特性。结果表明,该新方法简单、快速、准确且精密。

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