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 , 

 ISSN 2394-3211

Impact Factor: 6.222

 ICV - 79.57

Abstract

STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC DETERMINATION OF EBASTINE AS BULK DRUG AND IN TABLET DOSAGE FORM

Akshay S. Kale, Padmanabh B. Deshpande* and Sumit Saundale

ABSTRACT

The present work describes development and validation of a new simple, accurate, precise and selective stability- indicating high performance thin layer chromatographic (HPTLC) method for determination of Ebastine as bulk drug and in tablet dosage form. As stability testing is major step in the development of new drug as well as formulation, stress degradation studies were carried out according to ICH guidelines. Ebastine was found susceptible to all the analyzed stress conditions except photolysis. Chromatographic resolution of Ebastine and its degradation products was achieved by use of silica gel 60 F254 precoated aluminium plates as stationary phase and solvent mixture comprising of Ethyl acetate: Triethylamine (9.5: 0.5, v/v) as optimum mobile phase. Densitometric detection was carried out at 253 nm. The retention factor was found to be 0.59 ± 0.05. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness as per ICH guidelines. The developed method was found to be linear in the concentration range of 100-600 ng band-1. The developed method has been effectively applied for the drug estimation in tablet dosage form.

Keywords: Ebastine, HPTLC, Forced degradation, Tablet dosage form, ICH.


[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