Journal article Open Access

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF FEXOFENADINE HYDROCHLORIDE IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

D.Chinababu, K. Supraveena*, L. Siva Shankar Reddy, C. Madhusudhana Chetty, N. Madan Gopal


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    <subfield code="a">STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF FEXOFENADINE HYDROCHLORIDE IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM BY USING   RP-HPLC</subfield>
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    <subfield code="a">&lt;p&gt;&lt;em&gt;A simple, rapid and accurate method was developed for the determination of Fexofenadine Hydrochloride in bulk and pharmaceutical dosage form by RP-HPLC method using C&lt;sub&gt;18&lt;/sub&gt; column [4.6&amp;times;250mm,5&amp;mu;m] in binary gradient mode.&amp;nbsp; The mobile phase consisted of methanol and water in the ratio of 80:20 v/v. The flow rate was maintained at 1.2&amp;nbsp;mL/min and wavelength was maintained at 220 nm. The column oven temperature was maintained at 40&amp;deg;c. The retention time of Fexofenadine Hydrochloride was attained at 2.96 min. The method was linear over the concentration range from 7.5-40&amp;mu;g/mL and R&lt;sup&gt;2 &lt;/sup&gt;was found to be 0.999. The intraday and interday precision %RSD values were obtained &amp;lt;2.0. The LOD and LOQ were attained at 0.603 and 1.829&amp;mu;g/mL respectively. The accuracy results of the method&amp;nbsp;was obtained 98.37-99.84% at different levels of concentrations. The method was proved as robust after deliberately changed parameters of flow rate, mobile phase composition, temperature and wavelength. The method was shown ability to&amp;nbsp;words different stress conditions of acid, base, peroxide and UV-Light. The method was used for routine analysis of Fexofenadine hydrochloride in pharmaceutical dosage form.&lt;/em&gt;&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;&lt;em&gt;Key Words:&lt;/em&gt;&lt;/strong&gt;&lt;em&gt; Fexofenadine hydrochloride, RP-HPLC, Methanol, Stability studies.&lt;/em&gt;&lt;/p&gt;</subfield>
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