Hydrophilic interaction chromatography–electrospray ionization tandem mass spectrometric analysis of anastrozole in human plasma and its application to a pharmacokinetic study

Abstract

A hydrophilic interaction chromatography-electrospray ionization tandem mass spectrometric method was developed for determination of anastrozole in human plasma. Anastrozole and irbesartan (internal standard) were extracted from human plasma with a mixture of dichloromethane and methyl tert-butyl ether (30:70, v/v). Analysis of the analytes was performed on a Luna HILIC column with the mobile phase of acetonitrile-10 m m ammonium formate (95:5, v/v) and detected by electrospray ionization tandem mass spectrometry in the selected reaction monitoring mode. The standard curve was linear (r(2) = 0.9992) over the concentration range of 0.10-50.0 ng/mL using 200 μL of plasma sample. The coefficient of variation and relative error for intra- and inter-assay at four QC levels were 1.2-10.0% and -7.2-3.2%, respectively. The present method was applied successfully to the pharmacokinetic study of anastrozole after oral administration of 1 mg anastrozole tablet to healthy male volunteers.

Recent applications of hydrophilic interaction liquid chromatography in pharmaceutical analysis

“…Fast, sensitive, and specific determination of anastrozole (nonsteroidal aromatase inhibitor) , carboplatin (platinum compound used for treatment of nonsmall‐cell lung cancer and ovarian cancer) , tobramycin (broad spectrum aminoglycoside antibiotic) , vindesine (tubulin mitotic function inhibitor) , metformin in plasma with HILIC–MS/MS method were obtained and the corresponding method was applied to clinical/preclinical pharmacokinetic studies of the drug in healthy volunteers/patients/animals, respectively. Pharmacokinetic studies of different drugs with HILIC method, in fact, were following similar procedure.…”

“…Pharmacokinetic studies of different drugs with HILIC method, in fact, were following similar procedure. For example, employed irbesartan as IS, potent and selective nonsteroidal aromatase inhibitor anastrozole was determined by HILIC–MS/MS . The target compound was extracted from human plasma with LLE method, the standard curve was linear ( r 2 = 0.9992) over the concentration range of 0.10–50.0 ng/mL using 200 μL of plasma sample.…”