UPLC-LCMS-Based Method Development, Validation, Forced Degradation, and Impurity Profiling of Nirogacestat Drug Substance

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The UPLC-MS method successfully identifies degradation products of nirogacestat under various stress conditions, including acid and thermal environments.
Validation metrics showed excellent linearity (r² = 0.999) and all analytical parameters met acceptance criteria for reliable results.
Forced degradation studies highlighted diverse degradation products, emphasizing the method's capability to separate these from nirogacestat effectively.
This first validated stability-indicating method for nirogacestat enhances pharmaceutical quality assurance, indicating significant potential for regulatory compliance.

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UPLC-LCMS method demonstrates effective impurity profiling and stability analysis of nirogacestat, indicating robustness.

Thrinath et al. (2025) studied this question.

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