Aniline/Genotoxic Impurity Determination in Mesalamine Delayed Release Tablets by UPLC

نویسندگان

  • Ken-ichi Masumura
  • Toshihiko Kawamori
چکیده

Higher sample throughput with more information per sample may decrease the time to market, an important driving force in today’s pharmaceutical industry [1-3]. UPLC is a new category of separation technique based upon well-established principles of liquid chromatography, which utilizes sub-2 μm particles for stationary phase. These particles operate at elevated mobile phase linear velocities to affect dramatic increase in resolution, sensitivity and speed of analysis. Owing to its speed and sensitivity, this technique is gaining considerable attention in recent years for pharmaceuticals and biomedical analysis. In the present work, this technology has been applied to the method development and validation study of aniline determination in mesalamine delayedrelease dosage form.

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تاریخ انتشار 2013