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 ) , Scope Database , Academia , 

 ISSN 2394-3211

Impact Factor: 7.065

 ICV - 79.57

Abstract

DEVELOPMENT OF UV SPECTROSCOPY AND HPTLC METHOD FOR THE ANALYSIS OF DOFETILIDE AND ITS DEGRADATION PRODUCTS

Rapilane Krishnamurthi Sangeetha*, Thengungal Kochupapy Ravi and Muruganathan Gandhimathi

ABSTRACT

There are no reported methods till date for the analysis of dofetilide by UV spectroscopy and HPTLC method as a single drug. The aim of the present study is to develop a UV spectroscopic and HPTLC method and validate it according to ICH guidelines. The developed method was adopted for the stability testing of dofetilide. The maximum absorbance in UV spectroscopy was found at 231 nm with methanol as the solvent. The linearity was established at the concentration range of 2-18 mcg/ml with a correlation coefficient of 0.9987 .The Interday and intraday studies gave reproducible values with a % RSD of less than 1.The HPTLC method was developed with a mobile phase of Methanol: Toluene: Acetonitrile in ratio of 4:2:4. The Rf value was found to be 0.60 ± 0.02 with symmetrical peaks. The linearity range was 1000-10000 ng/spot with a correlation coefficient of 0.9961. The precision studies were found to be acceptable and % RSD value was found to be below 1. The drug was subjected to various stress conditions of acid hydrolysis, base hydrolysis, oxidation, photolysis and thermal degradation according to ICH guidelines. Successful separation of the drug peak and the degradants were found at well separated Rf value. The drug was found to be stable with acid hydrolysis, oxidation, base hydrolysis and thermal degradation at 40oC upto 4 hours with degradation of less than 10% and the degradation of more than 10% was found in elevated temperature of 40oC after 4 hours, 60oC, 80oC and photolysis. The drug solution was found to be stable at room temperature for 44 hours and in refrigeration for 7 days. The method developed has the merit of being simple, economical, sensitive and accurate for the analysis of dofetilide in bulk drugs.

Keywords: Dofetilide, UV Spectroscopy, HPTLC, Degradation studies, Stability Indicating method.


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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 ) Scope Database Academia