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

VALIDATED HPLC METHOD FOR DETERMINITION OF N-METHYL-OPHENYLENEDIAMINE DIHYDROCHLORIDE IN TELMISARTAN DRUG SUBSTANCES

Ritesh Kumar Srivastava* and S. Senthil Kumar

ABSTRACT

A reproducible RP-HPLC method was developed and validated with the aim of quantifying the levels of genotoxic impurity in telmisartan drug substances. A limit level concentration of 18.75 μg/g for N-methyl-Ophenylenediamine dihydrochloride was calculated by applying the concept of threshold of toxicological concern. The impurity was separated on Kromasil C18 150 x 4.6 mm, 5 μm analytical column with a mobile phase consisting of the buffer pH 3.0 and acetonitrile by using the gradient program at a flow rate 1.0 mL/min. The effluent was monitored by UV detection at 230 nm with column temperature maintained at 30 °C and the injection volume 20μL. The developed method was validated as per ICH guidelines in terms of specificity, limit of detection, limit of quantification, linearity, precision, accuracy and robustness. The LOD and LOQ value were found to be 2.53 μg/g and 7.52 μg/g and accuracy results were well in the range 90.68 to 110.21 %. The linearity curve showed the correlation coefficient of 0.9998 and method very sensitive. The validated method was applied for identification and quantification of impurity in different batches of the API.

Keywords: RP-HPLC, API, CH guidelines, Impurity, TTC, Validation.


[Full Text Article] [Download Certificate]

Citation

  All Since 2019
 Citation  3086  2560
 h-index  18  17
 i10-index  64  44

INDEXING

NEWS & UPDATION

  • EJPMR New Impact Factor

    EJPMR Impact Factor has been Increased to 7.065 for Year 2024.

  • EJPMR: FEBRUARY ISSUE PUBLISHED

    FEBRUARY 2024 issue has been successfully launched on 1 FEBRUARY 2024.

  • New Issue Published

    Its Our pleasure to inform you that, EJPMR 1 February 2024 Issue has been Published, Kindly check it on https://www.ejpmr.com/issue

  • Index Copernicus Value

    EJPMR Received Index Copernicus Value 79.57, due to High Quality Publication in EJPMR at International Level

  • Journal web site support Internet Explorer, Google Chrome, Mozilla Firefox, Opera, Saffari for easy download of article without any trouble.

    .

  • Article Invited for Publication

    Article are invited for publication in EJPMR Coming Issue

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