Journal article Open Access

A VALIDATED CHIRAL HPLC METHOD FOR THE ENANTIOMERIC PURITY OF ANAGLIPTIN

K. Durga Malleswar1, B. Venugopala Rao*1, S.Shylaja2.


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        <foaf:name>K. Durga Malleswar1, B. Venugopala Rao*1, S.Shylaja2.</foaf:name>
        <foaf:givenName>B. Venugopala Rao*1, S.Shylaja2.</foaf:givenName>
        <foaf:familyName>K. Durga Malleswar1</foaf:familyName>
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            <foaf:name>1Stereokem Private Limited. Plot No-36/A, IDA, Uppal, Hyderabad, Telangana, India. 2Chaitanya Bharathi Institute of Technology ,Gandipet, Hyderabad, Telangana, India.</foaf:name>
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    <dct:title>A VALIDATED CHIRAL HPLC METHOD FOR THE ENANTIOMERIC PURITY OF ANAGLIPTIN</dct:title>
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    <dct:issued rdf:datatype="http://www.w3.org/2001/XMLSchema#gYear">2019</dct:issued>
    <dcat:keyword>Anagliptin; Enantiomeric Separation; HPLC; Cellulose Based Stationary Phase And Validation.</dcat:keyword>
    <dct:issued rdf:datatype="http://www.w3.org/2001/XMLSchema#date">2019-07-31</dct:issued>
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    <dct:description>&lt;p&gt;An isocratic chiral phase high-performance liquid chromatographic method has been developed and validated to quantitation the (R)-isomer in Anagliptin. Separation was achieved in a Lux Cellulose-3 (250&amp;times;4.6mm, 5&amp;mu;m) column. The ratio of hexane, ethanol and diethyl amine in the mobile phase were optimized to obtain the best separation. UV detection was performed at 254 nm. The described method is linear over a range of LOQ &amp;ndash; 1.4 &amp;mu;g/mL of (R)-isomer. The mean recovery of (R)-isomer was found to be in the range of 100&amp;ndash;102%. The method is simple, accurate, selective and precise. The method can be used in the quality control of bulk manufacturing.&lt;/p&gt;</dct:description>
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