Abstract
The aim of the work is to develop and validate the bioanalytical RP-HPLC method for determination of acalabrutinib in plasma with nifedipine drug as internal standard. Liquid-liquid extraction with diethyl ether and methanol in the ratio of 50:50 (v/v) was used for the extraction of drugs from the biological matrix. The optimized chromatography conditions consist of methanol, acetonitrile and 0.1% orthophosphoric acid in the ratio of 45:35:20 (v/v) as a mobile phase with KNAUER Eurospher II C18 Column (250 × 4.6 mm, 5μ) as stationary phase. Isocratic elution with 0.9 mL flow separates acalabrutinib at 4.6 min and nifedipine at 6.8 min. The method was validated as per ICH guidelines and linear calibration curve was obtained for the peak area ratio of acalabrutinib and nifedipine compound across a range of 50-3000 ng/mL. Greater than 90% recoveries were obtained for acalabrutinib. The relative standard deviation (%RSD) was found to be < 5% for precision studies. Hence, the method was found to be suitable for the analysis of acalabrutinib in spiked human plasma and is used for the pharmacokinetic study
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