Development and validation of UV/VIS spectroscopy method for determination of atezolizumab in pharmaceutical products
Makaleler > Tam Makale · 2022
Yazarlar: Meliha EKİNCİ, Hasan AKBABA, RALPH SANTOS-OLIVEIRA, Derya İLEM ÖZDEMİR
Experimental Biomedical Research, Diğer Kurumların Hakemli Dergileri, Uluslararası, TR Dizin (Ulakbim), 2022, cilt 5, ss 175-182
DOI: 10.30714/j-ebr.2022275813
Özet
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 r 2 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.