Automated HPLC Screening and Method Development System

Library Number:
WA20277
Part Number:
WA20277
Author(s):
R Sneyers, W Janssens, A Pluym, I Somers [Johnson & Johnson Pharmaceutical R&D, div of Janssen Pharmaceutica, N.V.]
Source:
HPLC 2002; Montreal; 5-6 June 2002
Content Type:
Posters
Content Subtype:
HPLC

For the development of selective HPLC methods to be used for quantitative determination of impurities, degradants, excipients and active in the drug substance as well as in the drug product a screening concept is currently used. The concept is based on a matrix screening between different pH [2.5, 4.8, 7, 9] and stationary phases [Zorbax Extend C18, Bonus RP; Waters XTerra MS C18, XTerra RP18, XTerra Phenyl, SymmetryShield]. The screening module consists of 4 HPLC systems each operating with a different MS compatible mobile phase at a different pH. Each HPLC system is connected with a valve switcher to permit automated selection between 8 columns with different selectivity. After screening, 32 chromatograms for each sample have to be evaluated. The best separation is selected based on pH and column selectivity.


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