Overview of Forced Degradation Analysis for FDA Approved Antiretroviral agents: A Review

Abstract

Published on:August 2022Journal of Young Pharmacists, 2022; 14(3):273-282Review Article | doi:10.5530/jyp.2022.14.55 Authors:Suman Lamichhane1, Bhaswati Das2, Rudra Prasad Adhikari1, Mari Raju Jeyaprakash1*1Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, INDIA.2Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Nilgiris, Tamil Nadu, INDIA. Abstract: Forced degradation and its analysis play a crucial role in the development and production of pharmaceutical products at various stages. Such studies include the assessment of appropriate drug candidates, product development, as well as comparability studies, clarification of probable intermediates and identification of by-products, and the development of stability-indicating technologies. The stability of drugs can be analyzed with Forced degradation study, which gives perspective knowledge of the molecule’s stability as well as the degradant that is produced during the drug’s shelf life. In this review on stability-indicating methods for FDA approved antiretroviral drugs from (1987-2021) such as Zidovudine, Lamivudine, Nevirapine, Ritonavir, Abacavir, Efavirenz, Tenofovir, Atazanavir, Emtricitabine, Enfuvirtide, Fosamprenavir, Tipranavir, Darunavir, Maraviroc, Raltegravir Etravirine, Nevirapine, Rilpivirine, Dolutegravir, Cobistat, Doravirine, Fostemsavir, and Cabotegravir is mentioned and analytical tools like HPLC, LC-MS/MS, UPLC their different parameters for the chromatographic condition are mentioned. No such guideline is available that mentions the pH for hydrolysis, the temperature at which thermal deterioration occurs, and the concentration of oxidation agent for oxidative degradation. The regulatory necessities for the shortcomings of the above-mentioned methods were highlighted. As a result, this study addresses recent approaches for forced degradation by presenting techniques for accessing studies on degradation mechanisms, this review helps researchers to get information on stability-indicating methods for FDA Approved antiretroviral agents for their development and validation of stability indicating methods and the characterization of degradation products produced during degradation studies. Keywords: Stability indicating methods, Anti-retroviral, Chromatographic technique, HPLC, LC-MS/MS, UPLC.