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      Stress degradation studies and kinetic determinations of duloxetine enteric-coated pellets by HPLC.

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          Abstract

          A stability-indicating HPLC assay method was developed for the quantitative determination of duloxetine (DLX) in a pharmaceutical dosage form in the presence of its degradation products, and kinetic determinations were evaluated in acid conditions and UV-C radiation exposure. Chromatographic separation was achieved by use of an ACE C18 column (250 x 4.0 mm id, 5 microm particle size). The mobile phase was prepared by mixing aqueous 50 mM potassium phosphate buffer (pH 6.0 containing 0.3% triethylamine) and acetonitrile (60 + 40, v/v). DLX was rapidly degraded in an acid medium and in the presence of hydrogen peroxide and UV-C radiation; it was more stable in alkaline medium. The described method was linear over a range of 4.0-14.0 microg/mL for determination of DLX (r = 0.9998). The precision was demonstrated by the RSD of intraday (0.79-1.07%) and interday (0.85%) studies. The mean recovery was found to be 100.56%. The acid degradation of DLX in 0.1 M HCI solution showed an apparent zero-order kinetics (k = 0.177 microg/mL/min), and the photodegradation demonstrated an apparent first-order kinetics (k = 0.082 microg/mL/min). The developed method was found to be simple, specific, robust, linear, precise, and accurate for the determination of DLX in enteric-coated pellets.

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          Author and article information

          Journal
          J AOAC Int
          Journal of AOAC International
          1060-3271
          1060-3271
          February 15 2011
          : 93
          : 6
          Affiliations
          [1 ] Universidade Federal do Rio Grande do Sul (UFRGS), Faculdade de Farmácia, Programa de Pós-Graduação em Ciências Farmacêuticas, Porto Alegre, RS, Brazil. patriciagomes0@yahoo.com.br
          Article
          21313809
          73a47698-7078-4e36-a913-3f125dbdb1e8
          History

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