Method development and validation of almotriptan in human plasma by HPLC tandem mass spectrometry: application to pharmacokinetic study

Sci Pharm. 2012 Apr-Jun;80(2):367-78. doi: 10.3797/scipharm.1112-01. Epub 2012 Feb 27.

Abstract

A simple, sensitive and selective method has been developed for quantification of Almotriptan (AL) in human plasma using Almotriptan-d(6) (ALD6) as an internal standard. Almotriptan and Almotriptan-d(6) were detected with proton adducts at m/z 336.1→201.1 and 342.2→207.2 in multiple reaction monitoring (MRM) positive mode, respectively. The method was linear over a concentration range of 0.5-150.0 ng/mL. The limit of detection (LOD) and limit of quantification (LOQ) for Almotriptan were 0.2 pg/mL and 0.5 ng/mL, respectively. Liquid-liquid extraction was used followed by MS/MS (ion spray). The method was shown to be precise with an average within-run and between-run variation of 0.68 to 2.78% and 0.57 to 0.86%, respectively. The average within-run and between-run accuracy of the method throughout its linear range was 98.94 to 102.64% and 99.43 to 101.44%, respectively. The mean recovery of drug and internal standard from human plasma was 92.12 ± 4.32% and 89.62 ± 6.32%. It can be applied for clinical and pharmacokinetic studies.

Keywords: Almotriptan; HPLC; Human plasma; LLE; MS/MS; Pharmacokinetic study.