ArticleFrontiers in pharmacology2025
HPLC-UV method development and validation for anticancer drug sorafenib and the co-prescribed drug dexamethasone: application to pharmacokinetic evaluation of sorafenib nanoformulations.
Article in Frontiers in pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Sorafenib is used to treat advanced renal cell carcinoma. A high-performance liquid chromatography (HPLC) method was developed for the simultaneous determination of sorafenib with a commonly co-prescribed drug, dexamethasone, using meloxicam as an internal standard. The separation was achieved with acetonitrile and water with 0.05% trifluoroacetic acid (TFA), 65:35 v/v, eluted at 1.0 mL/min at a wavelength of 265 nm. The chromatographic separation was carried out on an ACE Generic C18 (5 μm, 4.6 mm × 150 mm, UK) column by injecting a sample volume of 20 µL into the HPLC system. The analytes were extracted with acetonitrile using the protein precipitation method. The chromatographic parameters were optimized, and the method was validated as per the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The internal standard concentration was kept constant (1.0 μg/mL) in all samples. The method was linear for both sorafenib and dexamethasone in the concentration ranges of 25-1,000 ng/mL and 50-2,000 ng/mL, respectively, with a correlation coefficient (r
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