Sorafenib.

Abstract

Sorafenib (BAY-43-9006), marketed by Bayer as Nexavar® (USA), is anticancer drug approved by US-FDA for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma. Sorafenib inhibited tumor growth and angiogenesis through targeting both the RAF/MEK/ERK pathway and receptor tyrosine kinases. This study presents a comprehensive profile of sorafenib, including detailed nomenclature, formula, elemental analysis, methods of preparation, physico-chemical characteristics, and methods of analysis (including spectroscopic, electrochemical, and chromatographic methods of analysis). Spectroscopic and spectrometric analyses include UV/vis spectroscopy, vibrational spectroscopy, nuclear magnetic resonance spectrometry ((1)H and (13)C NMR), and mass spectrometry. Chromatographic methods of analyses include thin layer chromatography and high-performance liquid chromatography. Only few stability indicating methods were found for quantification of sorafenib after exposing tablet dosage form to various stress conditions such as hydrolysis, oxidation, thermal stress, photo and UV light. However, none of these described methods were made to separate and quantify the degradation products. Pharmacology studies including pharmacodynamics, mechanism of action, pharmacokinetics and drug-drug interactions were also presented. An appropriate table and figures were attached to each of the above mentioned sections along with total of 55 references.