DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AVELUMAB AND AXITINIB

Abstract

A Simple, Rapid, Precise, Sensitive and Reproducible Reverse Phase High Performance Liquid
Chromatography (RP-HPLC) method has been developed for the Quantitative analysis of Avelumab and
Axitinib in Pharmaceutical dosage form. Chromatographic separation of Avelumab and Axitinib in was
achieved on Water Alliance-e2695 by using Symmetry C18 (150x 4.6 ,3.5µm ) column and the Mobile phase
containing ACN an 0.1% TFA in the ratio of 60:40%v/v. The Flow rate was 1.0ml/min. Detection was carried
out by Absorbance at 222nm using a Photodiode array detector at ambient temperature. The number of
Theoretical plates and Tailing factor for Avelumab and Axitinib were NLT 2000 and should NMT 2
respectively. The Calibration curve range of Peak Areas %Relative Standard Deviation should be less than
2.According to ICH Guidelines the method was validated. The method was found to be Simple, precise,
Accurate and Robust method for Quantitative Analysis of Avelumab and Axitinib study of its Stability.