The goal of this work was to create a new, fast, and accurate UV spectrophotometric method for quantifying acalabrutinib in pure and capsule dose forms. Water & ethanol were used in the ratio of 70:30 as a diluent. The highest absorbance of acalabrutinib was measured at 294 nm, and the linearity ranged from 2.5 to 15 g/ml. The regression equation for acalabrutinib was y= 0.0583x + 0.0053, with a correlation value of 0.9995. The percentage of recovery ranged from 99.87 to 100.71 percent. The relative standard deviation for intraday precision and interday precision was determined to be less than two. Acalabrutinib's LOD and LOQ were determined to be 0.006 g/ml and 0.197 g/ml, respectively. The spectrometric technique was validated in accordance with ICH criteria and was found to be suitable for routine quantitative measurement of acalabrutinib in pure and capsule dose forms. Keywords: Acalabrutinib, Method development, Ethanol
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
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