VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AXITINIB AND AVELUMAB BY USING ANALYTICAL QUALITY BY DESIGN (AQbD) METHOD

The quantitative measurement of Axitinib and Avelumab has been created using a simple, quick, precise, sensitive, and reproducible reverse-phasehigh-performance liquid chromatography (RP-HPLC) method. It is more difficult to analyse varying amounts of pharmaceutical active medicinal ingredients in dose forms without any interferences. Therefore, the objective of the current work is to estimate Axitinib and Avelumab simultaneously by adopting an Analytical Quality by Design (AQbD) arotatable central composite-based technique using RP-HPLC-based method development and validation. Axitinib and Avelumab were separated by chromatography using a Hyperclone 5µ BDS C18 130A (150 x 4.6 mm, 5μ) column and a mobile phase made up of Acetonitrile: 0.1% TEA pH-2.5/OPA in a ratio of 45:55 v/v. The flow rate was 1.2 ml/min, and a Photodiode Array Detector operating at room temperature was used to detect absorption at 219 nm. ICH criteria have been used to validate the offered techniques’ linearity, accuracy, precision, and other attributes. The degradation study’s findings showed that the medications deteriorated in high-stress situations. The chemical and pharmaceutical sectors might easily implement this unique AQbD-based analytical technique for routine analysis without any regulatory constraints.