Abstract

Objective: An easy, quick, precise, active and reproducible LC-MS/MS technique was developed for the bioanalytical method of Avelumab and Axitinib using Cytarabine as an internal standard. Methods: This article summarizes the recent progress on bioanalytical LC-MS/MS methods using waters x-bridge phenyl column (150x4.6 mm, 3.5µ) column and organic mobile phase of 0.1% Tri fluoro acetic acid and Acetonitrile in 50:50 ratio. Results: The calibration curve was linear in the range of 2-40 ng/ml for avelumab and 0.5-10 ng/ml axitnib. Accuracy, precision, recovery, matrix effect and stability results were found to be within the suitable limits. Simple and efficient method was developed and utilized in pharmacokinetic studies to see the investigated analyte in body fluids. Conclusion: The application denotes all the parameters of system suitability, specificity, linearity and accuracy are in good agreement with USFDA guidelines and applied effectively for the investigation of pharmacokinetic studies in rabbit.

Highlights

  • Avelumab is a fully human monoclonal antibody medication for the treatment of merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma [1]

  • No prospective clinical chemotherapy [4] have been performed and no regime has been officially approved for mmolCC treatment, combinations of platinum/etoposide have been commonly used and reasonably high objective response rates (ORRs) have been achieved, response time, is limited and no significant survival benefit has been reported

  • The mobile phase flow of 10 μl/min avelumab and axitinib are highly responsive in the positive ion mode to offer sensitivity and signal stability with the continuous flow to the electrospray ion

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Summary

Introduction

Avelumab is a fully human monoclonal antibody medication for the treatment of merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma [1]. In adults and children at least 12 y of age, treatment of a particular form of skin cancer, metastatic merkel cell carcinoma (MCC) [2]. Up to 12% of patients with MCC have incorrectly prognosed distant metastatic disease (mMcc). Progression to mmolcc is fruequentin up to 21 percent in patients with local or regional disease [3]. Avelumab gives side effects to a few patients after discontinuation, such as immune-related side effects and other common side effects, such as feeling tired, muscle pain, muscles, joints, tendons, ligaments, nerves, and increased liver enzymes [6,7,8,9,10]

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