Development and validation of UV/VIS spectroscopy method for determination of atezolizumab in pharmaceutical products

Meliha Ekinci; Hasan Akbaba; Ralph Santos-Oliveira; Derya Ilem-Ozdemir

doi:10.30714/j-ebr.2022275813

Meliha Ekinci Department of Radiopharmacy, Faculty of Pharmacy, Ege University, Bornova, Izmir, Turkey. http://orcid.org/0000-0003-1319-3756
Hasan Akbaba Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Ege University, Bornova, Izmir, Turkey. http://orcid.org/0000-0001-9273-6346
Ralph Santos-Oliveira Laboratory of Nanoradiopharmaceuticals, Nuclear Engineering Institute, Brazilian Nuclear Energy Commission, Rio de Janeiro, Brazil. http://orcid.org/0000-0002-0905-481X
Derya Ilem-Ozdemir Department of Radiopharmacy, Faculty of Pharmacy, Ege University, Bornova, Izmir, Turkey. http://orcid.org/0000-0002-1062-498X

DOI: https://doi.org/10.30714/j-ebr.2022275813

Keywords: Atezolizumab, monoclonal antibody, UV/Vis spectroscopy, validation, pharmaceutical products

Abstract

Aim: The aim of this study was to develop and validate a simple, fast, and reliable UV visible methodology for the determination of atezolizumab in pharmaceutical products.

Methods: The maximum wavelength of atezolizumab was determined using a UV/Vis spectrum and the calibration curve has been established. Validation studies were carried out to determine the reliability of the spectrophotometer method used in quantification of pharmaceutical products.

Results: According to the experimental data, the developed method was linear in a range varying from 0.10 to 1.50 mg.mL^-1 determined by 6 individuals calibrations points. The r² value was 0.9995 indicating a 99.95% correlation in linearity and precision. The robustness showed good and similar values and the limit of detection and limit of quantification were 0.005 mg.mL^-1 and 0.018 mg.mL^-1, respectively.

Conclusion: The data corroborates the reliability as applicability of the developed UV/Vis spectroscopy method for quantitatively determining the amount of atezolizumab in pharmaceutical products.