Abstract
A simple, sensitive and selective method has been developed for quantification of Almotriptan (AL) in human plasma using Almotriptan-d6 (ALD6) as an internal standard. Almotriptan and Almotriptan-d6 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.
Highlights
Almotriptan malate was obtained from USP and Almotriptan malate-d6 was obtained from clear synth Labs (P) Ltd, Mumbai, India
The extraction recovery of Almotriptan and Almotriptan-d6 from human plasma was determined by analyzing quality control samples
The MS optimization was performed by direct infusion of solutions of both Almotriptan and Almotriptan-d6 into the ESI source of the mass spectrometer
Summary
Almotriptan malate was obtained from USP and Almotriptan malate-d6 was obtained from clear synth Labs (P) Ltd, Mumbai, India. Liquid-Liquid extraction procedure was used in this study to isolate Almotriptan from the plasma samples For this purpose, 100 μL of Almotriptan-d6 (80 ng/mL) and 200 μL plasma (respective concentration of plasma sample) was added into riavials vortexed for 30 sec and 100 μl of 0.5 N sodium carbonate solution was added and vortexed for 10 min. The extraction recovery of Almotriptan and Almotriptan-d6 from human plasma was determined by analyzing quality control samples. Recovery at three concentrations (1.5, 75.0 and 105.0 ng/mL) was determined by comparing peak areas obtained from the plasma sample, and the standard solution was spiked with the blank plasma residue. The long-term stability of Almotriptan in quality control samples was evaluated by analysis after 65 days of storage at −30°C. Stability samples were processed and extracted along with the freshly spiked calibration curve standards. The pharmacokinetic parameters were computed using win nonlin® software version 5.2 and 90% confidence interval was computed using SAS® software version 9.2
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