Author/Authors :
Gmur، نويسنده , , Dennis J and Bredl، نويسنده , , Charles R and Steele، نويسنده , , Sharon J and Cai، نويسنده , , Shaopei and VanDevanter، نويسنده , , Donald R and Nardella، نويسنده , , Pasqua A، نويسنده ,
Abstract :
A precise and accurate HPLC assay for polymyxin E1 in rat and dog plasma has been validated. Samples and standards are extracted from plasma with a 96-well C8 extraction disk plate. Sample extracts are derivatized with dansyl chloride, and polymyxin E1 derivative is quantitated on a C8 column by HPLC with fluorescence detection. The assay is linear in the range of 0.050–5.00 μg/ml for polymyxin E1. The precision and accuracy of polymyxin E1 plasma assay was well within the recommended limits set in the FDA Guidance for Bioanalytical Method Validation. Polymyxin E1 stability in rat and dog plasma for 24 h at room temperature and through three freeze–thaw cycles was demonstrated.
