Journal
JOURNAL OF CHROMATOGRAPHY A
Volume 1083, Issue 1-2, Pages 58-62Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.chroma.2005.05.082
Keywords
hydrophilic interaction chromatography; HILIC; reversed-phase HPLC; pharmaceutical analysis; orthogonality; specificity; validation
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A hydrophilic interaction chromatography (HILIC) method has been developed and validated as a secondary or orthogonal method complementary to a reversed-phase HPLC (RP-HPLC) method for quantitation of a polar active pharmaceutical ingredient and its three degradation products. The HILIC method uses a diol column and a mobile phase consisting of acetonitrile/water and ammonium chloride. The compounds of interest show significant differences in retention behaviors with the two very different chromatographic systems, which are desired in developing orthogonal methods. The HILIC method is validated and has met all validation acceptance criteria for the support of drug development activities. (c) 2005 Elsevier B.V All rights reserved.
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