UPLC-LCMS-Based Method Development, Validation, Forced Degradation, and Impurity Profiling of Nirogacestat Drug Substance
The developed UPLC-MS method is the first validated stability-indicating technique for Nirogacestat, offering comprehensive impurity profiling. It is precise, accurate, linear, and robust, making it highly suitable for routine quality control and regulatory submission. This method enables the reliable detection of degradation products, thereby enhancing the safety and efficacy profile of Nirogacestat in pharmaceutical preparations.
Authors
- Manikandan Krishnan (ORCID: https://orcid.org/0000-0001-7434-8067)
- Sharad D. Mankumare
- K. S. Lakshmi
- S. R. Thrinath
Institutions
- SRM Institute of Science and Technology (IN)
- United States Pharmacopeial Convention (US)
Publication Details
- Journal
- Current Topics in Medicinal Chemistry
- Published
- 2025-08-15
- DOI
- https://doi.org/10.2174/0115680266407776250811045805
- Primary Topic
- Analytical Methods in Pharmaceuticals
- Type
- article
- Field-Weighted Citation Impact
- 0.00