EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

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 ISSN 2394-3211

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Abstract

A RAPID AND SENSITIVE VALIDATED HIGH PERFORMANCE LIQUIDCHROMATOGRAPHY METHOD FOR DETERMINATION OF RELATED SUBSTANCES IN METOPROLOL SUCCINATE (API)

Rajendra Phadke* and Dr. Amit Gosar

ABSTRACT

The purpose of this research study is to develop simple, precise, accurate and economical method for determination of related substances in Metoprolol Succinate API. The chromatographic method was developed on Durashell C18, (250 mm x 4.6 mm, 5 μm) column with binary gradient system and the mobiles phase used for speperation was (a) Dipotassium hydrogen phosphate buffer with pH 3.0 ± 0.05 adjusted with ortho phosphoric acid and mobile phase (b) was mixture of 5 volumes of Acetonitrile, 4 volumes of Methanol and 1 volume of Water. The detection of all related substances observed at lower walength 223 nm and The peak response of all related substances are very good, all impurities were detected at about 0.112ppm and quitified at 0.340ppm.The relative standard deviation of all impurities was below five percentage. Developed method was validated as per ICH guideline and found to be linear, accurate, specific, precise, and robust. The correlation coefficient of all the impurities was below 0.999 and impurites responces where liner from 0.340 ppm to 3.500 ppm. The obtained recovery of all the impurities between 90 to 110 percentage and solution stability of the sample solution was found to be stable up to 24 hrs, hence this method can be successfully applied for the determination of related substances in Metoprolol Succinate API.

Keywords: Metoprolol Succinate API, Binary Gradient, HPLC, method development, validation.


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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