ArticleScientific reports2025
Eco-conscious AQbD-guided stability-indicating RP-UPLC method for analysing Tovorafenib in bulk and dosage forms.
Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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2 citing papers in PubMed.
- A Box-Behnken design-assisted RP-HPLC method development and optimization for simultaneous determination of four antiviral drugs in pharmaceutical dosage forms.Scientific reports · 2026Article
- A novel green QbD-optimized RP-HPLC bioanalytical method for the simultaneous determination of doxorubicin and rifampicin in human plasma.BMC chemistry · 2026Article
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7 authors.
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Abstract
Tovorafenib is a type II RAF inhibitor recently approved by the FDA for relapsed or refractory paediatric low-grade glioma in children aged 6 months and older with BRAF fusions or V600E mutations, owing to its strong central nervous system penetration and absence of paradoxical MAPK pathway activation observed with type I inhibitors. This study developed and validated a fast, robust, and environmentally friendly reversed-phase ultra-performance liquid chromatography method for Tovorafenib quantification, employing ICH Q14 development, ICH Q2(R1) validation, and assimilating Analytical Quality by Design and green analytical chemistry principles. Chromatographic analysis was performed using a Waters Acquity UPLC BEH C18 column and 0.01 N Na₂HPO₄ in water: methanol (62:38 v/v) as the mobile phase at 0.29 ml/min, with PDA detection at 292 nm. The optimized approach exhibited excellent linearity (r² = 0.9997) and reproducibility (low %RSD). Forced degradation studies demonstrated Tovorafenib stability under most conditions, except during acid hydrolysis. Assessment with green chemistry tools yielded favourable eco-scores (ComplexMoGAPI 90, AGREE 0.61, BAGI 70, RAPI 92.5, EVG Q2, and RGBfast 97.5%). This validated RP-UPLC procedure offers reliable, sensitive, and sustainable Tovorafenib analysis, supporting both efficient pharmaceutical quality control and environmental sustainability.
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