August 17, 2025Separation Science PlusOpen Access

Analytical Quality by Design‐Based Stability‐Indicating UHPLC Method for Determination of Inavolisib in Bulk and Formulation

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Analytical method demonstrates specificity in quantifying inavolisib under various degradation conditions, suggesting reliability in quality control.

A stability-indicating UHPLC method quantifies inavolisib effectively within 3 minutes of run time, ensuring rapid analysis.
Method validation confirmed high accuracy, linearity (r² = 0.9998), and precision (%RSD < 1%), essential for pharmaceutical applications.
Forced degradation studies under acidic, basic, oxidative, and thermal conditions verified the method's robustness and specificity.
The analytical quality by design approach enables reliable assessment of critical method parameters, supporting routine quality control efforts.

Kumar et al. (2025) studied this question.

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Analytical method demonstrates specificity in quantifying inavolisib under various degradation conditions, suggesting reliability in quality control.