International Journal of Research and Scientific Innovation (IJRSI)
Stability Indicating Isocratic RP-HPLC Method for Simultaneous Estimation of Nivolumab and Relatlimab in Bulk and Pharmaceutical formulation
Published December 22, 2025 • Vol. 12, Issue 11, pp. 1846–1861Open Access
DOI: 10.51244/IJRSI.2025.12110162
Abstract
A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Nivolumab and Relatlimab in bulk and pharmaceutical dosage form. Chromatographic separation of Nivolumab and Relatlimab was achieved on Waters Alliance-e2695 by using Phenyl (250x 4.6mm, 5µ) column and the mobile phase containing Acetonitrile: TEA pH-2.5/OPA in the ratio of 50:50% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 222nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Nivolumab and Relatlimab were NLT 2000 and should not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Nivolumab and Relatlimab.
Keywords: Nivolumab, Relatlimab, RP-HPLC, Isocratic
| Journal | International Journal of Research and Scientific Innovation (IJRSI) |
|---|---|
| ISSN | 2321-2705 |
| Volume / Issue | Volume 12, Issue 11 |
| Pages | 1846–1861 |
| Publication date | December 22, 2025 |
| DOI | 10.51244/IJRSI.2025.12110162 |
| Publisher | RSIS International |
| License | Open Access |
How to cite this article
Dr Vamseekrishna G, D Bhargavi, J Deepthi Harika, M Nikhitha, K Lakshmi Prasanna, & M Srinivasa Sankar (2025). Stability Indicating Isocratic RP-HPLC Method for Simultaneous Estimation of Nivolumab and Relatlimab in Bulk and Pharmaceutical formulation. International Journal of Research and Scientific Innovation (IJRSI), 12(11), 1846-1861. https://doi.org/10.51244/IJRSI.2025.12110162
BibTeX
@article{Dr2025,
title = {Stability Indicating Isocratic RP-HPLC Method for Simultaneous Estimation of Nivolumab and Relatlimab in Bulk and Pharmaceutical formulation},
author = {Dr Vamseekrishna G and D Bhargavi and J Deepthi Harika and M Nikhitha and K Lakshmi Prasanna and M Srinivasa Sankar},
journal = {International Journal of Research and Scientific Innovation (IJRSI)},
volume = {12},
number = {11},
pages = {1846--1861},
year = {2025},
doi = {10.51244/IJRSI.2025.12110162},
publisher = {RSIS International}
}