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

A VALIDATED STABILITY INDICATING METHOD FOR THE DETERMINATION OF RELATED SUBSTANCES IN BELINOSTAT AND ITS DEGRADATION IMPURITIES BY RP-HPLC

Krishna Katta, Tirukkovalluri Siva Rao*, J. Mosesbabu and D. Venugopala Rao

ABSTRACT

A new sensitive, robust and stability indicating RP-HPLC method was developed for quantitative determination of related impurities and its degradation impurities in belinostat drug substance. The excellent chromatographic resolution was achieved on a Kromasil C18 (250 mm×4.6 mm, 4.0 μm) column with a mobile phase containing 0.1% perchloric acid in gradient combination with acetonitrile (ACN) at a flow rate of 1.0 mL/min and the eluent was monitored at 210 nm. The developed method is capable to separate all six known impurities and degradation impurities from Belinostat with a resolution (Rs) greater than 2.0. Performed method validation according to ICH guidelines, achieved the % RSD <0.2% in precision study. The Limit of detection and quantification for related impurities were 0.017 and 0.050 μg/mL respectively. Regrreation analysis proved that the method is linear with an r2 value (correlation coefficient) greater than 0.999 for all related impurities. The method is found to be accurate with % recoveries ranging from 98 to 100. Established homogeneity of belinostat peak and proved the stability indicating nature of the method by conducting forced degradation studies under elevated temperature, photolysis, Acid hydrolysis, Base hydrolysis, water hydrolysis, and oxidation.

Keywords: Belinostat; Validation; Impurities and Degradation Products.


[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 )