Increased Sensitivity, Improved Resolution and Faster Analysis Times For Compendial Methods

Dec 23 2009 Read 1252 Times

Author: Elli Abbasi, Jeff Layne, Heiko Behr, and Sky Countryman on behalf of Phenomenex Inc

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Determination of Impurities and Related Substances Using Newly Developed 2.6 μm Core-Shell Kinetex™ LC Columns

Presently, HPLC methods for the determination of impurities and related substances of drug products specified in monographs by the various Pharmacopoeial agencies typically employ LC columns packed with fully-porous 3 or 5 micron spherical silica chromatographic media. Due to the performance limitations of fully-porous 3 and 5 micron spherical silica chromatographic media, these analytical methods commonly require long analysis times.

Additionally, accurate quantitation of low-level impurities in routine LC-UV applications may be challenging due to the low intensity peaks generated by these columns. In recent years, smaller fully-porous LC particles
(sub-2 micron diameter) have been introduced that offer faster analysis times and generate higher intensity peaks for better sensitivity. Unfortunately, widespread adoption of this sub-2 micron HPLC column technology has been slowed since the smaller particle columns generate system backpressures that require specialised ultra-high pressure capable LC instrumentation.

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