A novel LC-MS/MS method development and validation for the determination of tezepelumab in rat plasma and its application in rat pharmacokinetic studies

By developing a quick, accurate, reproducible, and straightforward LC-MS/MS system and employing trastuzumab as an internal standard (IS), tezepelumab (TZP)s quantification was achieved. This study explores the most recent advancement in bioanalytical LC-MS/MS technologies utilizing a 150x4.6 mm, 3.5{micro} Waters Symmetry C18 column that was set for isocratic mode at ambient temperature. Methanol (MeoH): 0.1% Formic acid (FA) in 40:60 v/v at 1.0 ml/min was utilized as the mobile phase. The injection volume and runtime were 10 {micro}l and 5 minutes, respectively. TZPs retention time (RT) was 1.944 Minutes, and a chromatographic duration total of 5.0 min. With a correlation value (r2) of 0.99971, the technique was validated for Tezepelumab throughout a linear range of 6.00-120.00 ng/mL. Findings for precision, accuracy, recovery, matrix effect, and stability all occurred within acceptable limits. Below visual abstract is the concise summary of the article. O_FIG O_LINKSMALLFIG WIDTH=200 HEIGHT=91 SRC="FIGDIR/small/520442v1_ufig1.gif" ALT="Figure 1"> View larger version (21K): org.highwire.dtl.DTLVardef@15b24c1org.highwire.dtl.DTLVardef@ca2ddcorg.highwire.dtl.DTLVardef@189026borg.highwire.dtl.DTLVardef@1fdc1a3_HPS_FORMAT_FIGEXP M_FIG C_FIG