Stability Indicating RP-HPLC Method Development and Validation for the Estimation of Atezolizumab in Bulk and Its Injectable Dosage Form

摘要

Aim: A new simple reversed phase high performance liquid chromatographic method was developed for the estimation of Atezolizumab in bulk and its injectable formulation. Study Design: Quantitative and qualitative estimation and degradation studies of AZM by using Rp-HPLC. Place and Duration of Study: The work was performed at Santhiram College of Pharmacy and duration of study within 3 months. Methodology: The method was developed and validated and better results were obtained by using Polaris C18-A (150 mm—4.6 mm i.d., 5μm particle size column by using mobile phase 0.1% TFA in acetonitrile: water 90:10 v/v. The mobile phase flow rate was fixed 0.75 mL/min. Results: The mean retention time was 2.2 min. Correlation coefficient calibration curve within the detection range 75-225 μg/mL and R2 value was found to be 0.999. The Detection limit and Quantification limit were performed for AZM and found to be 15.24-50.80 μg/mL. The assay was perfomed and the percentage purity of the AZM was found to be 100.27%. Forced degradation studies were performed with acid, base, water, H₂O₂ and UV-light. Conclusion: The preliminary results indicated that the developed method was found to be a simple specific, precise, accurate and robust for the resolve of AZM in the bulk and marketed injectable formulations.