Stability Indicating RP-HPLC Method Development and Validation for the Estimation of Atezolizumab in Bulk and Its Injectable Dosage Form
D. China Babu *
Research Scholar, Research and Development, Jawaharlal Nehru Technological University Kakinada, Kakinada, A.P., India and Santhiram College of Pharmacy, Nandyal, Kurnool District, A.P., India.
C. Madhusudhana Chetty
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy, Nandyal, A.P., India.
Sk. Mastanamma
Department of Pharmaceutical Analysis, University College of Pharmaceutical Sciences, Nagarjuna Nagar, Guntur, A.P., India.
*Author to whom correspondence should be addressed.
Abstract
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.
Keywords: Atezolizumab, HPLC.