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 RP-HPLC CHROMATOGRAPHIC METHOD FOR THE ESTIMATION OF DOLUTEGRAVIR IN BULK AND TABLET DOSAGE FORM

Kolhe Mahesh Hari*, Phalke Shubhangi, Kakad Sudarshan Balasaheb and Dukre Tushar Pradip

ABSTRACT

A simple, sensitive, rapid and selective isocratic reversed phase High Performance Liquid Chromatographic (HPLC) method has been developed for Dolutegravir from bulk drug using a mobile phase consisting mixture of Methanol: Buffer KH2PO4 (80:20v/v) (pH 3) Composition of buffer: (0.272gm in 200ml HPLC water and pH adjusted to 3 using ortho Phosphoric acid) at the flow rate of 0.8 mL/min. A Cosmosil C18 (250 cm x 4.6 mm, 5 μm) column was used as stationary phase. The retention time of Dolutegravir found to be 5.698 min. The eluent were detected at 258 nm. Linearity was observed in the concentration range of 10-50 ppm for Dolutegravir. Percent recoveries obtained for Dolutegravir were 97%. The correlation coefficient for Dolutegravir was found to be 0.998. After performing analysis by different analysts, it was found that the RP-HPLC method for the determination of Dolutegravir was found to be Rugged. Percent RSD for robustness was well within the acceptable USP limits, ensuring that the proposed method was robust. The LOD were 0.060 μg/ml Dolutegravir,. For Dolutegravir, the LOQ were found to be 0.184 μg/ml. This demonstrated that the developed RP-HPLC method was simple, linear, precise, accurate, robust, and Rugged, could be conveniently adopted for the routine quality control analysis of Dolutegravir, from its pharmaceutical formulations and bulk drug.

Keywords: Dolutegravir (DTG), HPLC Method, Mobile phase.


[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 )