Stability‐Indicating Ultrahigh‐Performance Liquid Chromatography Method for Quantification of Related Impurities in Tovorafenib Bulk Drug Using an Analytical Quality by Design Approach

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This method quantifies related impurities in tovorafenib, suggesting it meets quality standards for pharmaceuticals.

The validated method indicates robust quantification of related impurities in tovorafenib, ensuring quality and safety.
Specificity and accuracy were demonstrated, with recovery rates between 99.0% and 99.9%, and limits of detection at 0.3 µg/mL.
Stability-indicating capability was confirmed under various stress conditions using forced degradation studies, validating the method's reliability.
Analytical quality by design principles were implemented to optimize critical parameters like flow rate, temperature, and buffer pH.

Kumar et al. (2025) studied this question.

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