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RASĀYAN - Journal Of Chemistry Vol.4, No.2, 223-497, April-June (2011)

DETERMINATION OF SORAFENIB IN BULK AND TABLET FORMULATION BY A NEW VALIDATED REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Authors: S.VenkataRao1, G.Ramu1, A.Biksham Babu1 T.Neeharika2 and C.Rambabu1*

*E-mail: rbchintala@gmail.com

A rapid, precise, economical and accurate reverse phase HPLC method was developed and validated for estimation of Sorafenib (SFN) in bulk and formulations. The chromatographic resolution was achieved using acetonitrile and 0.1M disodium phosphate buffer (55: 45 V/V) as a mobile phase, UV detection at 248 nm, Interersil ODS C18 column and flow rate 1mL/min. The extraction recovery of Sorafenib from its formulation dosage form (tablets) was found to be greater than 99.48% and the calibration curve was linear (r2 = 0.9998) over Sorafenib concentration ranging from 20 to 120 μ g /mL. The method had an accuracy of greater than 99%. Limit of detection and limit of quantification were found to be 0.7466 μ g /mL and 2.3300 μ g /mL respectively. The developed method was validated statistically and recovery studies were found to be satisfactory.

Keywords : Sorafenib, Renal cell carcinoma (RCC), Heptocellular carcinoma [HCC] and colorectal cancer [CRC], RP-HPLC, CC, LOD AND LOQ.

Page No. : 477-480 RJC-769