Abstract
DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF NEW ANTICANCER AGENT ACALABRUTINIB IN BULK AND ITS PHARMACEUTICAL FORMULATION

Priyanka P., Shyamala*, Mounika. D, Nadeemuddin and Abdul Moyeez

ABSTRACT

A novel isocratic reverse phase liquid chromatography method for determination of Acalabrutinib was developed and validated after optimization of various chromatographic conditions.Chromatographic conditions used are stationary phase kromosilC18 column (250×4.6 mm5m) with mobile phase 0.1% O-Phosphoric acid and methanol in ratio of 50:50 and flow rate was maintained at 1.0 ml/min, detection wavelength was 236nm,column temperature was set to 300C and diluents was mobile phase conditions were finalized as optimized method.System suitability parameters were studied by injecting the standard six times and results were under acceptance criteria. Linearity study was carried out between 25% to 150% levels, R value was found to be 0.4 for repeatability and 0.8for intermediate precision.LOD and LOQ are 0.73μg/ml respectively. The retention time of Acalabrutinib was 2.6min. The linearity for Acalabrutinib was in the range of 25-150 μg mL-1 with coefficient of correlation 0.999. The proposed method was validated with respect to linearity, accuracy, precision and robustness.

Keywords: Acalabrutinib, RP-HPLC, Validation.


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