Determination of ADB-BUTINACA in rat plasma by UPLC-MS/MS and its application

Abstract A fast, accurate, sturdy, and sensitive UPLC-MS/MS method was developed to measure the levels of ADB-BUTINACA in rat plasma for a pharmacokinetic study. The ADB-BUTINACA and midazolam (internal standard) were separated on a UPLC BEH C18 column (2.1 mm × 50 mm, 1.7 μm) using a gradient elution of acetonitrile and water (0.1% formic acid) as the mobile phase. ADB-BUTINACA and midazolam were detected in multiple reaction monitoring (MRM) mode for quantitative analysis, the mass detection was performed on a positive electrospray ionization (ESI) source. The calibration curve displayed excellent linearity from 1 to 1,000 ng mL −1 , with a lower limit of quantification of 1.0 ng mL −1 and a limit of detection of 0.3 ng mL −1 . The precision for both inter-day and intra-day assays was below 14%, while accuracy ranged from 92% to 111%. The method also showed an average recovery between 87% and 90%, with a matrix effect ranging from 104% to 111%. The data was acceptable according to the guidelines of the US Food and Drug Administration (FDA). This newly validated quantitative method successfully supported the pharmacokinetic study of ADB-BUTINACA.