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强制降解和杂质剖析:分析视角的最新趋势。

Forced degradation and impurity profiling: recent trends in analytical perspectives.

机构信息

School of Pharmaceutical Sciences, Rajiv Gandhi Technological University, Bhopal 462 033, Madhya Pradesh, India.

出版信息

J Pharm Biomed Anal. 2013 Dec;86:11-35. doi: 10.1016/j.jpba.2013.07.013. Epub 2013 Jul 31.

Abstract

This review describes an epigrammatic impression of the recent trends in analytical perspectives of degradation and impurities profiling of pharmaceuticals including active pharmaceutical ingredient (API) as well as drug products during 2008-2012. These recent trends in forced degradation and impurity profiling were discussed on the head of year of publication; columns, matrix (API and dosage forms) and type of elution in chromatography (isocratic and gradient); therapeutic categories of the drug which were used for analysis. It focuses distinctly on comprehensive update of various analytical methods including hyphenated techniques for the identification and quantification of thresholds of impurities and degradants in different pharmaceutical matrices.

摘要

本文简要介绍了 2008-2012 年期间药物(包括活性药物成分(API)和药物制剂)降解物和杂质分析方法的最新进展趋势。这些最新的降解物和杂质分析方法的研究趋势主要根据发表年份、色谱柱、分析基质(API 和剂型)和洗脱类型(等度洗脱和梯度洗脱)以及用于分析的药物治疗类别进行讨论。本文重点介绍了各种分析方法的最新进展,包括用于不同药物基质中杂质和降解物的鉴定和限量测定的联用技术。

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