建立了同时测定多潘立酮、酒石酸美托洛尔和酚红原位单通肠通透性的高效液相色谱方法

IF 0.6 Q4 PHARMACOLOGY & PHARMACY Journal of Research in Pharmacy Pub Date : 2023-01-01 DOI:10.29228/jrp.376
Saniye Özcan, E. Çağlar, M. Kaynak, N. Okur
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引用次数: 0

摘要

肠灌注法(SPIP)是测定药物肠通透性最常用的方法之一。美托洛尔作为酒石酸盐和酚红经常被用作灌注试验的参比化合物,以评估本研究的重点成分马来酸多潘立酮的渗透系数。本研究的目的是建立并验证一种同时检测马来酸多潘立酮、美托洛尔和酚红的反相液相色谱技术,用于肠道灌注研究。色谱柱为C18,色谱柱为150 × 1.5 mm, 5.0µm,流动相为甲醇:20 mm磷酸二氢钾缓冲液43:57,v/v;pH值3.1。该方法使用FDA的稳定性、线性度、精密度和准确度标准进行验证。所有的校准曲线均为线性r 2 bb0 0.99。该方法的系统适宜性参数是所有分析物的要求限值。在这种新方法的帮助下,原位肠通透性实验可以很容易地标准化。
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A newly developed and fully validated HPLC method for simultenous determination of in-situ single pass intestinal permeability of domperidone, metoprolol tartarate and phenol red
: One of the most popular methods for figuring out a drug’s intestinal permeability is the intestinal perfusion (SPIP) approach. Metoprolol as tartrate and phenol red are frequently utilized as reference compounds in perfusion tests to assess the permeability coefficient of the study’s focus component, Domperidone maleate. Our study’s goal was to create and validate a reversed-phase liquid chromatographic technique for the simultaneous detection of Domperidone maleate, metoprolol, and phenol red for use in intestinal perfusion studies. The analysis was performed on a C18 column 150 × 1.5 mm, 5.0 µm using a mobile phase consisting of methanol: 20 mM potassium dihydrogen phosphate buffer 43:57, v/v ; pH 3.1. The procedure was validated using the FDA’s standards for stability, linearity, precision, and accuracy. All calibration curves were linear r 2 > 0.99. The system suitability parameters of the method are the required limits all analytes. The in situ intestinal permeability experiments can easily be standardized with the help of this newly created and proven approach.
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来源期刊
Journal of Research in Pharmacy
Journal of Research in Pharmacy PHARMACOLOGY & PHARMACY-
CiteScore
1.00
自引率
12.50%
发文量
80
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