Abstract

A highly sensitive and simple high-performance liquid chromatographic–tandem mass spectrometric (LC–MS-MS) assay is developed and validated for the quantification of Naftopidil in human plasma. Naftopidil is extracted from human plasma by methyl tertiary butyl ether and analyzed using a reversed-phase gradient elution on a discovery C 18 5μ (50×4.6) column. A methanol: 2mM ammonium formate (90:10) as mobile phase, is used and detection was performed by MS using electrospray ionization in positive mode. Propranolol is used as the internal standard. The lower limits of quantification are 0.495ng/mL. The calibration curves are linear over the concentration range of 0.495–200.577ng/mL of plasma for each analyte. This novel LC–MS-MS method shows satisfactory accuracy and precision and is sufficiently sensitive for the performance of pharmacokinetic studies in humans.

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