Work

Impurity profiling and forced degradation studies of angiotensin (AT1) blockers: A review

Year: 2025

Type: article

Abstract: This review looks at the latest developments in some analytical techniques employed for impurity profiling and forced degradation studies for sartans, or angiotensin (AT1) receptor blockers, which are widely used to treat hypertension. Interest in the impurities found in APIs is constantly growing. Several regulatory bodies now require both purity and impurity profiles. The review also gives overview of impurities relevant to products and manufacturing processes, as well as the minimal concentration values that are allowed for elemental, inorganic, and organic impurities. This study aims to give a general overview of the analytical methods that are currently being used to evaluate forced degradation studies and angiotensin blocker impurity profiling. Diverse analytical methods, including UHPLC-MS/MS, LC-FD, UV-diode array detector, HPLC NMR, Supercritical fluid extraction, as well as FT-IR, have been utilized to evaluate the impurity profiling of angiotensin receptor blocker drugs with realistic retention lengths. Methods such as HPLC coupled with MS/MS were developed to lower detection and quantification limitations. In-depth explanations of the three most widely used sartans including losartan, valsartan, and olmesartan as well as a summary of the analytical techniques that have been used so far to distinguish degradants from impurities have been included.

Source: Current Pharmaceutical Analysis

DOI: 10.1016/j.cpan.2025.01.005

Authors: Ramanlal N. Kachave, Deepali D. Bhandari, Prashant L. Pingale, Dattatraya M. Shinkar, Sunil V. Amrutkar

Institutions: Gokhale Education Society, Savitribai Phule Pune University

Language: English

Topic: Analytical Methods in Pharmaceuticals

Subfield: Analytical Chemistry

Field: Chemistry

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $2,100