How to Cite: Kale, S. A., & Shaikh, K. S. (2022). Validated UV-Vis spectrophotometric method for the estimation of Sorafenib Tosylate in bulk and nanoparticles. International Journal of Health Sciences, 6(S3), 4011–4019. https://doi.org/10.53730/ijhs.v6nS3.6719 International Journal of Health Sciences ISSN 2550-6978 E-ISSN 2550-696X © 2022. Manuscript submitted: 27 Dec 2021, Manuscript revised: 09 March 2022, Accepted for publication: 18 April 2022 4011 Validated UV-Vis spectrophotometric method for the estimation of Sorafenib Tosylate in bulk and nanoparticles Sangita A. Kale (M.pharm), PES's Modern College of Pharmacy, Nigdi, 411044, Pune, Maharashtra, India Email: sangitakale109@gmail.com Karimunnisa S. Shaikh (M.pharm,PhD), PES's Modern College of Pharmacy, Nigdi, 411044, Pune, Maharashtra, India Abstract---It was noticed from the standard databases such as Scopus, PubMed, ScienceDirect, etc. that a limited UV-Vis spectrophotometric method has been reported for estimating Sorafenib (SOR), but no sophisticated analytical methods have been ever reported in any database for estimating SOR in nanoparticles. The present research involved the establishment of an economic, accurate, robust, and precise analytical method for the quantitative determination of SOR in bulk and nanoparticles utilizing a new validated spectrophotometric method. The spectrophotometric analysis was carried out using double-beam ultraviolet-visible spectrophotometer was employed in developing a new method using methanol and water at a ratio of 80:20 v/v and λmax of 265 nm. The technique was verified using the Q2A and Q2B guidelines of ICH. The newly developed UV-Vis method had desired linearity over the range of 2-12 μg/mL; along with excellent precision, accuracy, ruggedness, and robustness characteristics as observed from % RSD values of less than 2. The present study concluded that the developed UV-Vis method has desired linearity, precision, accuracy, ruggedness, and robustness, and will serve as an excellent technique for the determination of sorafenib in both bulk and nanoparticles without the interference of commonly used chemicals or solvents. Keywords---sorafenib, ultraviolet visible, bulk, nanoparticles. Introduction