Development and Validation of an LC-MS/MS Method for Quantitative Analysis of Mirtazapine in Human Plasma

Abstract

Mirtazapine (MTZ) is an antidepressant drug, which belongs to the chemical class of piperazinoazepines. A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed for the quantification of MTZ in plasma at the concentrations associated with therapy. Diazepam (DZP) was used as internal standard, added to 200 μL of plasma sample prior to a liquid-liquid extraction using hexane. Chromatographic separation was achieved on an Agilent ® Eclipse XDB C-18 column (100 × 2.1 mm, 3.5 μm) in isocratic mode at 40˚C. Mobile phase was 10 mM ammonium acetate/acetonitrile/formic acid (60/40/0.1, v/v/v) at a constant flow rate of 0.5 mL·min -1 . The injection volume was 10 L and the total run time was 3.2 min. The method shows selectivity and linearity. The detection and quantitation limits were established at 0.17 and 0.50 ng·mL -1 , respectively. The extraction recoveries for MTZ and DZP were found to be between 84.9 and 93.9%. The intra-day and inter-day precision and accuracy fulfill at the international acceptance criteria. The method shows to be stable for the studied parameters. Therefore, a rapid, specific, and sensitive LC-MS/MS method for quantification of MTZ in human plasma was developed and can be used in therapeutic drug monitoring of this drug.

Liquid chromatography–tandem mass spectrometry method for the quantification of a potent H3 receptor antagonist conessine in serum and its application to pharmacokinetic studies

“…Stability in autosampler, bench top, freeze-thaw, long-term and processed sample were evaluated. [27][28][29] Autosampler stability. In autosampler stability testing, the QC samples at three concentration levels in two sets were prepared and stored in the autosampler.…”

“…Stability in autosampler, bench top, freeze–thaw, long-term and processed sample were evaluated. 27–29…”

Method development and validation for the estimation of mirtazapine by using UV spectrophotometer with different order of derivatives

“…[6] Development and validation of an LC-MS/MS method for quantitative analysis of Mirtazapine in human plasma were also reported. [7]Validation of a GC/MS method for the determination of alkaline drugs in whole blood was also reported. [8] Development and validation have been reported of a stability-indicating HPTLC method for the determination of Mirtazapine as a bulk drug and in pharmaceutical formulation.…”

Pharmacokinetics and Bioequivalence of Methotrexate in Human Plasma Studied by Liquid Chromatography-Mass Spectrometry (LC-MS)

“…This parameter was defined as the lowest concentration level resulting in a peak area of three times the baseline noise. The limit of quantification (LOQ) was defined as the lowest concentration level that provided a peak area with a signal-to-noise ratio higher than 5, with precision (% CV) within ± 20% and accuracy (% recovery) between 80% and 120% (24,25).…”