Acalabrutinib is aided in the treatment of various cancers, which acts by inhibiting Bruton tyrosine kinase. Acalabrutinib belongs to the imidazopyrazine class consisting of a chiral carbon, resulting in two enantiomers. Currently, no methods exist for the separation and quantification of these enantiomers. A novel and selective enantiomeric chromatographic technique has been established to estimate the enantiomeric purity of acalabrutinib. Chiral separation was carried out on an immobilized amylose-based chiral stationary phase with methyl tert-butyl ether/ethanol/ethylenediamine (60:40:0.1% v/v) mixture as a mobile phase. The total runtime is 20 min, and the resolution (Rs ) between the enantiomers was more than 2.5. The detection and quantification thresholds for the R-enantiomer were 0.06 and 0.2 μg mL-1 , respectively, for a test concentration of acalabrutinib (1000 μg mL-1 ). The linearity of the technique for the R-enantiomer was excellent (R2 > 0.999) over the range from the limit of quantification to 0.3%. Recovery of the R-enantiomer was ranged from 95% to 102%, indicating the greater accuracy of the technique. For a 48-h research period, the drug was shown to be stable.
Keywords: HPLC; acalabrutinib; chiral; enantiomers; polysaccharide.
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