Degradation studies of drug give insightful information about the intrinsic stability of the molecule, the possible degradents formed during shelf life and thus, aid in the subsequent development of its stable formulation. For identification and characterization of degradents and impurities formed during stress studies, various analytical techniques are required including hyphenated techniques. Chromatographic methods play a crucial role in the field of degradation and impurity profiling. Many of these methods have been introduced for the qualitative and quantitative analysis of drugs and their formulations. This article encompasses current trends in analytical methods used for degradents, foreign matter, genotoxic impurity, and impurity profiling studies of the last five years (2013-2017). It further provides an insight into the development of various analytical methods such as hyphenated and non-hyphenated techniques those used in the analysis of pharmaceuticals. Various components used in chromatographic development such as mobile phase, buffer solutions, elution modes, columns, column temperature, and detectors are emphasized. Techniques developed by systematic Analytical Quality by Design (AQbD) approach are also discussed. Additionally, the in silico toxicity prediction studies and the methods developed for genotoxic impurity analysis are briefly explained.

中文翻译：

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降解研究和杂质分析进展的五年一次回顾：工具视角统计。

药物的降解研究提供了有关分子固有稳定性，在保质期内形成的可能降解物的有见地的信息，因此有助于其稳定制剂的后续开发。为了鉴定和表征在应力研究过程中形成的降解物和杂质，需要各种分析技术，包括连字技术。色谱方法在降解和杂质分析领域中起着至关重要的作用。已经引入了许多这些方法，用于对药物及其制剂进行定性和定量分析。本文涵盖了过去五年（2013-2017年）用于降解物，异物，遗传毒性杂质和杂质分布研究的分析方法的当前趋势。它进一步洞察了各种分析方法的发展，例如在药物分析中使用的联用和非联用技术。强调了色谱开发中使用的各种组分，例如流动相，缓冲液，洗脱模式，色谱柱，色谱柱温度和检测器。还讨论了通过系统的设计分析质量（AQbD）方法开发的技术。此外，简要解释了计算机毒性预测研究和为遗传毒性杂质分析开发的方法。并强调检测器。还讨论了通过系统的设计分析质量（AQbD）方法开发的技术。此外，简要解释了计算机毒性预测研究和为遗传毒性杂质分析开发的方法。并强调检测器。还讨论了通过系统的设计分析质量（AQbD）方法开发的技术。此外，简要解释了计算机毒性预测研究和为遗传毒性杂质分析开发的方法。