Determination of Milnacipran in Human Plasma Using GC-MS


UÇAKTÜRK E. , SAFAK C.

CHROMATOGRAPHIA, vol.72, pp.111-119, 2010 (Journal Indexed in SCI) identifier identifier

  • Publication Type: Article / Article
  • Volume: 72
  • Publication Date: 2010
  • Doi Number: 10.1365/s10337-010-1607-9
  • Title of Journal : CHROMATOGRAPHIA
  • Page Numbers: pp.111-119

Abstract

A new, simple, and fully validated gas chromatography-mass spectrometry (GC-MS) method was presented for quantitative analysis of milnacipran (MNP) in human plasma. MNP was efficiently derivatized with N-methyl-N-trimethylsilyltrifluoroacetamide (MSTFA) before analysis. The role of catalyst, temperature, time, solvent on the trimethylsilylation reaction were evaluated. The proposed method was fully validated by assessment of the following parameters: limits of detection and quantitation, precision, accuracy, linearity, specificity, stability, extraction recovery and robustness/ruggedness. The limit of quantitation (LOQ) was 30 ng mL(-1). The calibration curve was linear (r (2) > 0.9988) in the range 30-500 ng mL(-1). The method was found specific, precise, accurate, selective and reliable according to validation data. This developed method was successfully applied to determine the steady state concentration of MNP in patients.