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Assay Method for Levothyroxine
Superior Resolution, Reproducibility, & Peak Shapes Compare toUSP Method
Discussion The USP assay method for levothyroxine requires that a resolution of not less than 5.0 must be demonstrated between levothyroxine and related compound liothyronine. A chromatogram obtained from following the USP method using a Type-B silica based L10 column is shown in Figure B. The average resolution between the two compounds over five runs is 2.8, which does not satisfy the system suitability for resolution for this assay. Figure A shows the five-run overlay obtained from a method developed with the Cogent Phenyl Hydride column. The average resolution in this case was 5.3. In addition, the peak shapes and reproducibility were far superior for the Phenyl Hydride method. | |||||||||||||||||||||||||||||||
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