LC-MS Method Development and Validation for the Estimation of Nivolumab and Relatlimab in Rat Plasma and Its Pharmacokinetic Study

Abstract

Melanoma, pulmonary, kidney cell cancer, malignancy of the head and neck, urothelial, malignant colon cancer, esophageal carcinoma of the squamous cells, liver cancer, gastric cancer, and gastrointestinal junction cancer are among the cancers that can be treated with Nivolumab, anti-cancer drug. Therefore, one of the most important fields of contemporary pharmaceutical analysis is the development, validation, and pharmacokinetic investigation of Nivolumab and Relatlimab in rat plasma. The current application aims to show up when pharmacokinetic assessment of Nivolumab and Relatlimab in rat plasma using LC-MS/MS and bioanalytical system validation is carried out. The current application aims to provide evidence up in the occurrence that a pharmacokinetic analysis of Relatlimab and Nivolumab in rat plasma using LC-MS/MS and bioanalytical system validation will be performed. The improved procedure employed a Waters X-bridge phenyl (250mmx4.6mm, 5µm) column with a flow rate of 1 mL/min. The mobile phase in this experiment was a combination of acetonitrile and buffer (1 mL TFA in 1 litre of water). Nivolumab and Relatlimab differentiate themselves by employing Trastuzumab for the internal standard and 10-minute run duration. Relatlimab linearity range covers 10 and 200 % of the rat plasma, while Nivolumab is between 6 and 240 ng/mL and 2-80 ng/mL. The value of R2 for each analyte was 0.999. According to USFDA criteria, our work shows that all requirements, including exactness, recovery, accuracy, and stability, were fulfilled. Pharmacokinetic investigations of Nivolumab and Relatlimab using rat plasma may be examined using this method.