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

Autor: Madhusudhana Reddy Nimmakayala, Deepti Kolli, J.V. Shanmukha Kumar
Rok vydání: 2022
DOI: 10.1101/2022.12.14.520442
Popis: 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 150×4.6 mm, 3.5µ 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 µl and 5 minutes, respectively. TZP’s 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.Abstract Figure
Databáze: OpenAIRE