Analytical Method Development and Validation for Determination of Acalabrutinib by Using RP-HPLC

Abstract

A unique, selective, and precise RP-HPLC technique for quantifying acalabrutinib in pure and pharmaceutical dose form was developed and validated. Acalabrutinib is an oral kinase inhibitor with an antineoplastic effect and an apoptosis inducer. It is used for the treatment of adult patients with mantle cell lymphoma (MCL). The isolation was obtained on the BDS C18 column (150 x 4.6mm) with a 5µ particle size. At a flow rate of 1ml/min, an optimised mobile phase of 0.1 percent potassium di hydrogen ortho phosphate and acetonitrile (70:30 v/v) was utilised. The wavelength was chosen to be 294nm. Acalabrutinib had a retention time of 2.585 minutes. Acalabrutinib linearity was found to be 12.5-75 g/ml. The linearity equations for acalabrutinib were y = 71296x + 49305, with a correlation coefficient of 0.999. The precision percent RSD was found to be less than 2%. Acalabrutinib recovered at a rate of 99.81 percent. The LOD and LOQ for acalabrutinib were obtained as 0.408 µg/ml and 1.236 µg/ml respectively. The projected technique was recognized to be precise, accurate and ideal for use in QC laboratories for quantitative analysis of both individual and mixed dosage forms of pharmaceuticals. Keywords: RP-HPLC, Method Development and Validation