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  <front>
    <journal-meta>
      <journal-title-group>
        <journal-title>American Journal of PharmTech Research</journal-title>
        <abbrev-journal-title abbrev-type="publisher">AJPTR</abbrev-journal-title>
      </journal-title-group>
      <issn pub-type="epub">2249-3387</issn>
      <publisher>
        <publisher-name>undefined</publisher-name>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="publisher-id">AJPTR64015</article-id>
      <title-group>
        <article-title>Dissolution Method Development and Validation of Dabigatran Etexilate Mesylate Capsules by RP-HPLC</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <name>
            <surname>Bhavani</surname>
            <given-names>G.</given-names>
          </name>
          <xref ref-type="aff" rid="aff1"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Hussain</surname>
            <given-names>Syed Shahed</given-names>
          </name>
          <xref ref-type="aff" rid="aff1"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Ranjith</surname>
            <given-names>Ch.</given-names>
          </name>
          <xref ref-type="aff" rid="aff1"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Kumar</surname>
            <given-names>A. Ashok</given-names>
          </name>
          <xref ref-type="aff" rid="aff1"/>
        </contrib>
      </contrib-group>
      <aff id="aff1">Vijaya college of pharmacy, Munaganur (Village), Hayathnagar (Mandal), Ranga reddy (District), Hyderabad, Telangana (State) – 501511, India.</aff>
      <pub-date pub-type="epub" iso-8601-date="2016-08-01">
        <month>08</month>
        <day>01</day>
        <year>2016</year>
      </pub-date>
      <volume>6</volume>
      <issue>4</issue>
      <abstract>
        <p>The article aims at developing simple, fast and effective dissolution method for Dabigatran etexilate mesylate capsules by RP-HPLC and validate as per ICH guidelines. The optimized RP-HPLC method for dissolution studies uses a reverse phase column, Phenomenex Luna C18 (250 X 4.6 mm;5μ), a mobile phase of triethylammonium phosphate buffer (pH 3.0):acetonitrile in the proportion of 40:60 v/v, diluent as 0.01N HCl, flow rate of 1.0ml/min, injection volume as 20µl. and a detection wavelength of 341nm using a UV detector. The optimized dissolution conditions include, 0.01N HCl as dissolution media, apparatus as USP Type 1 Basket, rpm as 100, dissolution media temperature as 37±0.5ºC, dissolution volume as 500ml, dissolution time point as 30mts, working concentration of standard and sample as 5µg/ml and a detection wavelength of 341 nm. The developed method resulted in Dabigatran etexilate exhibiting linearity in the range 1.25-10μg/ml. System precision and intra-day precision is exemplified by relative standard deviation of 1.59% and 2.21% respectively. Method was found to be rugged/inter day precise as %RSD was found to be 3.25. Percentage Mean recovery was found to be greater than 80% at all the three levels by absolute method during accuracy studies. LOD and LOQ for Dabigatran etexilate were found to be 0.05ng/ml and 5ng/ml respectively. Hence it can be concluded that effective dissolution method by RP-HPLC is developed and validated as per ICH guidelines which can be applicable in various pharmaceutical industries.</p>
      </abstract>
      <kwd-group kwd-group-type="author">
        <kwd>Dabigatran etexilate</kwd>
        <kwd>Dissolution</kwd>
        <kwd>RP-HPLC</kwd>
        <kwd>ICH guidelines</kwd>
        <kwd>Validation</kwd>
      </kwd-group>
    </article-meta>
  </front>
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