| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 9744926 | Analytical Biochemistry | 2005 | 7 Pages |
Abstract
A reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed for detection and quantification of free maytansinoid drug in disulfide-linked conjugates between monoclonal antibodies and the maytansinoid drug DM1 (MAb-DM1). Mobile phases and gradient conditions were optimized for separation of several DM1-related free drug species from MAb-DM1 conjugates. The selectivity, linearity, and reproducibility of the method are reported. Reduction of the disulfide-linked DM1 followed by RP-HPLC allowed estimation of purity of MAb-linked DM1 as well as recovery of l-DM1. The method was also used to estimate drug per MAb ratios, which were consistent with those determined by UV spectroscopy.
Keywords
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Michael S. Fleming, Wei Zhang, John M. Lambert, Godfrey Amphlett,