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HPTLC 法测定药物制剂中的有效成分:方法开发和验证步骤的综述。

HPTLC methods to assay active ingredients in pharmaceutical formulations: a review of the method development and validation steps.

机构信息

Tanzania Food and Drugs Authority, P.O. Box 77150, Dar es Salaam, Tanzania.

出版信息

J Pharm Biomed Anal. 2012 Jul;66:11-23. doi: 10.1016/j.jpba.2012.03.034. Epub 2012 Mar 28.

Abstract

High-performance thin-layer chromatography (HPTLC) is still increasingly finding its way in pharmaceutical analysis in some parts of the world. With the advancements in the stationary phases and the introduction of densitometers as detection equipment, the technique achieves for given applications a precision and trueness comparable to high-performance liquid chromatography (HPLC). In this review, the literature is surveyed for developed and validated HPTLC methods to assay active ingredients in pharmaceutical formulations published in the period 2005-2011. Procedures and approaches for method development, validation and quantitative assays are compared with the standard ways of conducting them. Applications of HPTLC in some other areas are also briefly highlighted.

摘要

高效薄层色谱(HPTLC)在世界上某些地区仍越来越多地应用于药物分析。随着固定相的进步以及密度计作为检测设备的引入,该技术在给定的应用中实现了与高效液相色谱(HPLC)相当的精度和准确性。在这篇综述中,调查了 2005-2011 年期间发表的用于测定药物制剂中活性成分的已开发和验证的 HPTLC 方法的文献。方法开发、验证和定量分析的程序和方法与标准方法进行了比较。还简要介绍了 HPTLC 在其他一些领域的应用。

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