Gel permeation chromatographic method for drug protein binding studies

M. Bhatia, S. Jadhav, Santosh S. Kumbhar
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引用次数: 2

Abstract

The estimation of individual plasma protein in free and bound form with analytes has importance in pharmacokinetics study. Albumins and globulins are most abundantly found in plasma and plays crucial role in plasma protein binding. The present communication deals with the development of gel permeation chromatographic method for the estimation of plasma protein binding studies for ketoprofen, tapentadol and furaltadone. The method was developed using WATER system with Ultrahydrogel column (7.8 x 300 mm i.d.), refractive index detector (1.00 to 1.75 RIU) and Rheodyne injection valve fitted with a 20μl sample loop using 0.1% sodium nitrate as a mobile phase. The method was developed by studying binding above drugs with most of plasma proteins. These complexes have shown linearity in range of 100 to 300μg/ml of these drugs. The developed method has been validated using USFDA guidelines. The developed bioanalytical method is accurate, precise, and selective and sensitive for quantification of plasma proteins bound drugs. The further optimization of method using other standard plasma proteins will explore its applicability in pharmacokinetic and biopharmaceutical studies of most of drugs.
凝胶渗透色谱法用于药物蛋白结合研究
血浆游离蛋白和结合蛋白在药代动力学研究中具有重要意义。白蛋白和球蛋白在血浆中含量最多,在血浆蛋白结合中起着至关重要的作用。本文介绍了凝胶渗透色谱法在酮洛芬、他他多和呋喃他酮血浆蛋白结合研究中的应用。该方法采用WATER系统,采用超水凝胶色谱柱(7.8 × 300 mm i.d),折射率检测器(1.00 ~ 1.75 RIU)和Rheodyne进样阀,样品环为20μl,流动相为0.1%硝酸钠。该方法是通过研究上述药物与大多数血浆蛋白的结合而发展起来的。这些配合物在100 ~ 300μg/ml范围内呈线性关系。所开发的方法已通过USFDA指南的验证。该方法对血浆蛋白结合药物的定量具有准确、精确、选择性和敏感性。使用其他标准血浆蛋白进一步优化方法,将探索其在大多数药物的药代动力学和生物制药研究中的适用性。
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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