Quinquennial Review of Progress in Degradation Studies and Impurity Profiling: An Instrumental Perspective Statistics

Abstract

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.

Keywords:

• Analytical techniques
• degradation profiling
• genotoxic impurities
• impurity profiling
• quality by design

Acknowledgement

The authors are thankful to School of Pharmacy & Technology Management, SVKM’s NMIMS, Shirpur campus for providing all the facilities, required for this article.