Validation of a Serum Analysis Method to Analyze Antihistamines by Capillary Electrophoresis

J. Peris-Vicente, S. Carda‐Broch, J. Esteve-Romero
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Abstract

The validation of an electrophoresis-based analytical method to quantify 17 antihistamines in pharmaceutical formulations and serum is described. Then, whether the methodology provides true values with low uncertainty and is able to detect the concentration range level of analyte usually found in the matrix was evaluated. The analytical method was validated following the recommendations of an official guide to provide more reliability to the results. The ICH Harmonized Tripartite Guideline was selected because it was especially developed for analysis of drugs. The guide and the following required validation parameters, selectivity, calibration range, linearity, limit of detection, limit of quantification, inter- and intraday accuracy and precision, and robustness, were described. The method was inexpensive, fast, simple, environmentally friendly, and useful for routine analysis. The methodology was successfully validated and applied to commercial pharmaceutical formulations and spiked blank serum samples.
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毛细管电泳血清抗组胺分析方法的验证
一种基于电泳的分析方法的验证,定量17抗组胺药物配方和血清描述。然后,评估该方法是否能提供具有低不确定度的真实值,并能够检测出通常在基质中发现的分析物的浓度范围水平。根据官方指南的建议对分析方法进行了验证,以提高结果的可靠性。选择ICH协调三方指南是因为它是专门为药物分析而制定的。描述了该指南和以下要求的验证参数,选择性,校准范围,线性,检出限,定量限,日内和日内准确度和精密度以及鲁棒性。该方法经济、快速、简便、环保,可用于常规分析。该方法已成功验证并应用于商业药物配方和加标空白血清样品。
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