Development and Validation of A UV Method for Quantitative Estimation of Satralizumab

We introduce an innovative and affordable UV spectrophotometric method for accurately measuring Satralizumab in pharmaceutical products.Through thorough investigation, we identified Satralizumab's absorption peak at 275.1 nm.The technique demonstrates remarkable linearity across 7.5-45 μg/mL, boasting a correlation coefficient of 0.999.Precision was confirmed by both intra-and inter-day studies, with %RSD values consistently under 2%, reflecting exceptional reliability.Following ICH Q2 (R1) guidelines, the method achieved 98.8% recovery and 99.5% assay accuracy.This approach not only fulfills regulatory requirements but also ensures rapid, precise, and reproducible quality assessment of Satralizumab in pharmaceutical formulations.