EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : Google Scholar , Indian Science Publications , InfoBase Index (In Process) , SOCOLAR, China , Research Bible, Fuchu, Tokyo. JAPAN , International Society for Research activity (ISRA) , Scientific Indexing Services (SIS) , Polish Scholarly Bibliography , Global Impact Factor (GIF) (Under Process) , Universal Impact Factor , International Scientific Indexing (ISI), UAE  , Index Copernicus , CAS (A Division of American Chemical Society) USA (Under Process) , Directory of Open Access Journal (DOAJ, Sweden, in process) , UDLedge Science Citation Index , CiteFactor , Directory Of Research Journal Indexing (DRJI) , Indian citation Index (ICI) , Journal Index (JI, Under Process) , Directory of abstract indexing for Journals (DAIJ) , Open Access Journals (Under Process) , Impact Factor Services For International Journals (IFSIJ) , Cosmos Impact Factor , Jour Informatics (Under Process) , Eurasian Scientific Journal Index (ESJI) , International Innovative Journal Impact Factor (IIJIF) , Science Library Index, Dubai, United Arab Emirates , Pubmed Database [NLM ID: 101669306] (Under Process) , IP Indexing (IP Value 2.40) , Web of Science Group (Under Process) , Directory of Research Journals Indexing , Scholar Article Journal Index (SAJI) , International Scientific Indexing ( ISI ) , 

 ISSN 2394-3211

Impact Factor: 6.222

 ICV - 79.57

Abstract

DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING ASSAY METHOD FOR ESTIMATION OF SORAFENIB TOSYLATE IN PURE AND PHARMACEUTICAL DOSAGE FORM BY HPTLC

Saroja P. Adepawar* and Shailaja B. Jadhav

ABSTRACT

A simple, specific and rapid validated stability indicating HPTLC method has been developed for estimation of Sorafenib Tosylate in bulk and pharmaceutical dosage form. The separation was carried out on Merck TLC aluminium sheets precoated with silica gel 60F254 were used for chromatographic separation. Combination of toluene: ethyl acetate (3:7 v/v) was selected as the mobile phase. Detection was done by UV absorbance mode at wavelength 265nm. Sorafenib Tosylate showed well defined and sharp peak at Rf 0.45 ± 0.02. The calibration curve of drug was found linear in the concentration range 200–1000 ng/band for Sorafenib Tosylate. The developed method was precise, robust and the % RSD was found less than 2%. Stress degradation study includes acid and base hydrolysis, oxidation, thermal and photolytic stress conditions in accordance with International Conference on Harmonization (ICH) guidelines Q1 (R2). The proposed method can be used for routine quality control analysis of bulk drug and marketed formulation containing Sorafenib Tosylate.

Keywords: Sorafenib Tosylate, HPTLC, Validation, Stability.


[Full Text Article]

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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI )