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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="doi">10.5281/zenodo.10691639</article-id>
      <article-id pub-id-type="publisher-id">AJPTR141001</article-id>
      <title-group>
        <article-title>RP-HPLC Stability Indicating Analytical Method Development and Validation For The Simultaneous Estimation Of Tezacaftor, Ivacaftor and Elexacaftor In API and Pharmaceutical Dosage Form</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <name>
            <surname>Divya</surname>
            <given-names>Mekala.</given-names>
          </name>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Vinutha</surname>
            <given-names>K.</given-names>
          </name>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Sridevi</surname>
            <given-names>P</given-names>
          </name>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Raju</surname>
            <given-names>M Bhagawan</given-names>
          </name>
        </contrib>
      </contrib-group>
      <pub-date pub-type="epub" iso-8601-date="2024-02-01">
        <month>02</month>
        <day>01</day>
        <year>2024</year>
      </pub-date>
      <volume>14</volume>
      <issue>1</issue>
      <abstract>
        <p>We developed a straightforward, precise method for the simultaneous estimation of Ivacaftor, Elexacaftor and Tezacaftor in both bulk and tablet dosage forms. The chromatography analysis was performed using a Discovery C18 column measuring 150 x 4.6 mm with a 5µm particle size. The mobile phase, composed of Acetonitrile: Methanol: 0.1% OPA (10:35:55 v/v) was pumped at a flow rate of 0.9 ml/min, with the temperature maintained at 28°C. The optimized wavelength for detecting 3 drugs was set at 278.0 nm. Retention times were measured at 2.537 min, 2.089 min, and 3.090 min, respectively. The method precision showed low %RSD values, with 0.4 for Ivacaftor, 0.3 for Elexacaftor and 0.4 for Tezacaftor. Recovery percentages were determined as 99.79% for Ivacaftor, 99.72% for Elexacaftor and 100.05% for Tezacaftor. Furthermore, the LOD and LOQ values derived from the regression equations for  Ivacaftor, Elexacaftor and Tezacaftor i.e  y = 22674x + 2799.3, y = 21285x + 4513.2 and y = 21548x + 869.63  were found to be 0.06 ppm and 0.22 ppm, 0.18 ppm and 0.19 ppm , 0.07 ppm and 0.57 ppm  respectively. With reduced retention times, this method offers simplicity and cost-effectiveness, making it suitable for routine quality control testing.</p>
      </abstract>
      <kwd-group kwd-group-type="author">
        <kwd>Tezacaftor</kwd>
        <kwd>Ivacaftor</kwd>
        <kwd>Elexacaftor</kwd>
        <kwd>RP-HPLC</kwd>
      </kwd-group>
    </article-meta>
  </front>
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