LC-MS/MS Determination and Pharmacokinetics Study of Apremilast after Oral Administration in Rabbits

Abstract:

Objectives: A selective and reproducible method has been optimised for evaluation of Apremilast in rabbit biological matrices by UPLC-ESI-MS/MS. Methods: The analytical technique was implemented to quantify the apremilast in rabbit plasma samples with Apremilast-D5 as deuterated internal standard. The chromatographic separation tuned with 10mM Ammonium Acetate Buffer (pH: 4.0): Methanol: Acetonitrile, (20:40:40%, v/v/v) using the CORTECS C₁₈, 2.7 μ.m, 4.6 m.m X 150 m.m analytical column with analysis time four minutes. The flow of mobile phase through column is 0.5 m.L/min. The mass spectrometric ions of Apremilast and Apremilast-D5 obtained were m/z 461.5→257.1 and 466.5→257.1. Results: The curve indicates correlation coefficient (r²) was superior than 0.998 with linear range of 0.03-48.0 n.g/m.L. The developed method was tuned to apply efficaciously for analyzing the pharmacokinetic parameters of Apremilast in rabbit plasma samples. Conclusion: An accurate and reproducible novel method was fabricated for estimation of Apremilast in rabbit biological matrices by UPLC-ESI-MS/MS will be used for regular analysis and appropriate for therapeutic drug monitoring.

Key words: Apremilast, Rabbit plasma, UPLC-ESI-MS/MS, Bio-analysis, Pharmacokinetic, Therapeutic drug monitoring.