Development and Validation of RP-LC Method for the Determination of Cinnarizine/Piracetam and Cinnarizine/Heptaminol Acefyllinate in Presence of Cinnarizine Reported Degradation Products.

Analytical Chemistry Insights Pub Date : 2013-10-07 eCollection Date: 2013-01-01 DOI:10.4137/ACI.S12478

Ola M El-Houssini, Nagwan H Zawilla, Mohammad A Mohammad

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引用次数: 13

Abstract

Specific stability indicating reverse-phase liquid chromatography (RP-LC) assay method (SIAM) was developed for the determination of cinnarizine (Cinn)/piracetam (Pira) and cinnarizine (Cinn)/heptaminol acefyllinate (Hept) in the presence of the reported degradation products of Cinn. A C18 column and gradient mobile phase was applied for good resolution of all peaks. The detection was achieved at 210 nm and 254 nm for Cinn/Pira and Cinn/Hept, respectively. The responses were linear over concentration ranges of 20-200, 20-1000 and 25-1000 μgmL(-1) for Cinn, Pira, and Hept respectively. The proposed method was validated for linearity, accuracy, repeatability, intermediate precision, and robustness via statistical analysis of the data. The method was shown to be precise, accurate, reproducible, sensitive, and selective for the analysis of Cinn/Pira and Cinn/Hept in laboratory prepared mixtures and in pharmaceutical formulations.

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肉桂碱降解产物中肉桂碱/吡拉西坦和肉桂碱/乙酰化庚胺的RP-LC测定方法的建立与验证。

建立了特定稳定性指示反相液相色谱法(SIAM)，用于测定肉桂碱(Cinn)/吡拉西坦(Pira)和肉桂碱(Cinn)/乙酰化七胺酸(Hept)的降解产物。采用C18色谱柱和梯度流动相对各峰进行了较好的分辨。Cinn/Pira和Cinn/Hept的检测波长分别为210 nm和254 nm。Cinn、Pira和Hept分别在20 ~ 200、20 ~ 1000和25 ~ 1000 μgmL(-1)浓度范围内呈线性关系。通过对数据的统计分析，验证了该方法的线性度、准确度、重复性、中间精密度和稳健性。结果表明，该方法对实验室配制的混合物和制剂中的Cinn/Pira和Cinn/Hept具有精确、准确、重复性、敏感性和选择性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Analytical Chemistry Insights

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