Recent Progresses in Analytical Perspectives of Degradation Studies and Impurity Profiling in Pharmaceutical Developments: An Updated Review

Abstract

Forced degradation studies have been used to simplify analytical methodology development and achieve a deeper knowledge about the inherent stability of active pharmaceutical ingredients (API) and drug products. This provides insight into degradation species and pathways. Identification of impurities in pharmaceutical products is closely related to the selection of the most appropriate analytical methods like HPLC-UV, LC-MS/MS, LC-NMR, GC-MS, and capillary electrophoresis. Herein, recent trends in analytical perspectives during 2018–April 14, 2021, are discussed based on forced and impurity degradation profiling of pharmaceuticals. Literature review showed that several methods have been used for experimental design and analysis conditions such as matrix type, column type, mobile phase, elution modes, detection wavelengths, and therapeutic category. Thus, since these factors influence the separation and identification of the impurities and degradation products, we attempted to perform a statistical analysis for the developed methods according to the abovementioned factors.

Keywords:

• Active pharmaceutical ingredients
• forced degradation
• HPLC-UV
• impurity profiling
• LC-MS/MS

Acknowledgement

The authors thank Mashhad University of Medical Sciences (MUMS) for help and support.

Dsiclosure statement

No potential conflict of interest was reported by the authors.

Authors’ contribution

FH and OR supervised the research. MJ reviewed the literature, collected and analyzed the data, and wrote the manuscript. BSFB revised and approved the final version of the manuscript. MA curated the data and revised the manuscript. All authors approved this version of the manuscript.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.