International Journal of Drug Delivery Technology
Volume 14, Issue 2

Development and Validation of New LC-MS/MS Bioanalytical Method of Tremelimumab in Rat Plasma by Using Nivolumab as Internal Standard and Its Application with Pharmacokinetic Studies

Alapati Sahithi, Asha Deepti*

Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh, India. 

Received: 15th April, 2023; Revised: 01st May, 2024; Accepted: 19th May, 2024; Available Online: 25th June, 2024 

ABSTRACT

Nivolumab was decided to be used as the IS. To separate the drugs, an isocratic mobile phase of acetonitrile (ACN): Ammonium formate containing formic acid (70:30) was adopted and delivered at 1-mL/min, along with a 150 x 4.6 mm x 3.5 µm Alliance, e2695 Luna Phenyl Hexyl column. Drug and IS, both of which display proton adducts approximately m/z 146.3685 to 120.0638 and m/z 143.7695 to 76.7964, might be detected simultaneously using MRM-positive modalities. Over a linearity level of

2.00 to 40.00 ng/mL, the method had a correlation value (r2) of 0.99977. The accuracy and precision of this method during the day ranged from 89.85 to 102.89% and 0.19 to 2.81%, respectively. Tremelimumab was reported to remain stable during three freeze-thaw cycles, benchtop tests, and postoperative stability studies. Cmax and Tmax values were acquired directly from experimental data. Cmax and Tmax averaged 18.024 ng/mL and 6 hours, respectively. At t1/2 of 18 hours, plasma levels

began to fall. The obtained AUC024 and AUC0 values were 257 and 257 ng h/mL, respectively.

Keywords: Tremelimumab, Nivolumab, Pharmacokinetics, MRM, Ammonium formate, Formic acid. International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.2.20

How to cite this article: Sahithi A, Deepti A. Development and Validation of New LC-MS/MS Bioanalytical Method of Tremelimumab in Rat Plasma by Using Nivolumab as Internal Standard and Its Application with Pharmacokinetic Studies. International Journal of Drug Delivery Technology. 2024;14(2):727-731.

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