Stability indicating RP-HPLC method development and validation for the determination of Acalabrutinib in bulk drug and capsule dosage form

Abstract

Simple, rapid, accurate, precise and reproducible stability indicating RP-HPLC method for the estimation of Acalabrutinib in bulk and Capsule dosage form was developed and validated as per ICH guidelines. The separation was done using Zodiasil C18 150 x 4.6 mm, 5 µ column. The mobile phase (Water and methanol 60:40%v/v) was pumped at 0.8ml/min and effluent were detected at 230nm using a PDA detector. The retention time was 2.76 ± 0.1 min and the method produced a linear response in the concentration range of 25-150 µg/ml (r2- 0.9997). In recovery studies, %RSD from reproducibility was found to be below 2%. LOD and LOQ were 0.03 µg/ml and 0.08µg/ml respectively. The drug was subjected to different stress conditions such as acidic, alkaline, oxidative, photothermal and hydrolysis. The drug showed more degradation in acidic condition and no degradation was observed in hydrolysis and photo condition. The developed RP-HPLC method was found to be effective, sensitive and specific for the estimation of Acalabrutinib in bulk and Capsule dosage form.