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An LC-MS/MS bioanalytical method was qualified for the quantification of the test substance in rat plasma and tissue (liver, spleen, kidney). In this method, the test substance was extracted from 20 µL of rat plasma or 300 mg tissue homogenate by Liquid Liquid Extraction (LLE) prior to LC-MS/MS analysis. A total of 160 samples were analyzed. Phenobarbital was used as the internal standard (IS).

The assay range was from 1.00 to 100 ng/mL for the test substance in rat plasma or tissue homogenate. All bioanalytical runs met the predefined run acceptance criteria, except one run (AB002). Run AB002 was rejected because the QC samples did not adhere to the criteria. The samples from run AB002 were reanalyzed in run AB003.

The results demonstrate that the qualified method is suitable for the measurement of the test substance in rat plasma and rat tissue homogenate by LC-MS/MS in the concentration range of 1.00 - 100 ng/mL. The method proved selective, precise, accurate, and reproducible measurements. The test substance and internal standard were found to be stable during sample collection, sample handling, sample processing, and after repeated freezing and thawing. In addition, the method shows no analytical carry-over.