LIQUID CHROMATOGRAPHY/POSITIVE-ION ELECTROSPRAY TANDEM MASS SPECTROMETRY ASSAY FOR NISOLDIPINE IN HUMAN PLASMA AND ITS APPLICATION TO A PHARMACOKINETIC STUDY

Abstract

A rapid, sensitive, and specific method was developed for the identification and quantitation of the calcium antagonist nisoldipine in human plasma by liquid chromatography coupled with tandem mass spectrometry using nimodipine as an internal standard. Nisoldipine was extracted from human plasma (0.2 mL) by a liquid/liquid procedure using diethyl ether as the eluent. The mass spectrometer was operated in the multiple reaction-monitoring scan mode using an electrospray ionization source. The analyte and internal standard could be separated in 2 min on a C₁₈ analytical column with a mobile phase of acetonitrile:water (66:34, v/v) at a flow rate of 0.4 mL · min⁻¹. The calibration curve of nisoldipine in human plasma was linear over the range from 0.1 to 30 ng · mL⁻¹ (r² ≥ 0.9994). The precision, determined as the relative standard deviation of replicate quality controls, was 9.35% (0.2 ng · mL⁻¹), 11.61% (2.0 ng · mL⁻¹), and 4.68% (20 ng · mL⁻¹). This method was successfully applied to pharmacokinetic studies and determination of nisoldipine concentration in vivo.

Keywords:

• clinical application
• human plasma
• LC-MS-MS
• nisoldipine
• pharmacokinetic study

ACKNOWLEDGMENTS

Renwang Liu and Zenghui Teng contributed equally to this work.

Notes

Renwang Liu and Zenghui Teng contributed equally to this work.