Open AccessDevelopment and Validation of Novel HPLC Bioanalytical Analysis Method for Acalabrutinib: An Anticancer Drug in Human Plasma
Author(s) -
G. Atchutarama Krishna,
P. Srinivasarao,
T. B. Patrudu,
R. Chidanandaswamy
Publication year - 2020
Publication title -
asian journal of chemistry/asian journal of chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.145
H-Index - 34
eISSN - 0975-427X
pISSN - 0970-7077
DOI - 10.14233/ajchem.2020.22844
Subject(s) - bioanalysis , chemistry , chromatography , calibration curve , extraction (chemistry) , methanol , acetonitrile , high performance liquid chromatography , detection limit , organic chemistry
The aim of the work is to develop and validate the bioanalytical RP-HPLC method for determinationof acalabrutinib in plasma with nifedipine drug as internal standard. Liquid-liquid extraction withdiethyl ether and methanol in the ratio of 50:50 (v/v) was used for the extraction of drugs from thebiological matrix. The optimized chromatography conditions consist of methanol, acetonitrile and0.1% orthophosphoric acid in the ratio of 45:35:20 (v/v) as a mobile phase with KNAUER EurospherII C18 Column (250 × 4.6 mm, 5μ) as stationary phase. Isocratic elution with 0.9 mL flow separatesacalabrutinib at 4.6 min and nifedipine at 6.8 min. The method was validated as per ICH guidelinesand linear calibration curve was obtained for the peak area ratio of acalabrutinib and nifedipinecompound across a range of 50-3000 ng/mL. Greater than 90% recoveries were obtained foracalabrutinib. 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 plasmaand is used for the pharmacokinetic study