| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 1213219 | Journal of Chromatography B | 2012 | 7 Pages |
A rapid, sensitive and reliable LC–MS/MS method was developed and validated for the simultaneous determination of ranolazine and its three metabolites, CVT-2514, CVT-2738, and CVT-4786, in human plasma. The plasma samples were prepared by protein precipitation. Chromatographic separation was achieved on a Gemini C18 column (50 mm × 2.0 mm, 5 μm) using methanol: 5 mM ammonium acetate as the mobile phase with gradient elution. Mass detection was carried out by electrospray ionization in both positive and negative ion multiple reaction monitoring (MRM) modes. The calibration curves were linear over a concentration range of 4–2000 ng/mL for ranolazine, 4–1000 ng/mL for CVT-2514 and CVT-2738 and 8–1000 ng/mL for CVT-4786. The intra-day and inter-day accuracy and precision were within the acceptable limits of ±15% at all concentrations. The method was successfully applied for the simultaneous estimation of ranolazine and its three metabolites in human plasma from a clinical pharmacokinetics study.
► A rapid and sensitive LC–MS/MS assay has been developed and validated. ► Ranolazine and three metabolites were simultaneously determined in human plasma. ► The LLOQ was 4 ng/mL for ranolazine, CVT-2514 and CVT-2738, and 8 ng/mL for CVT-4786. ► The method was applied to a pharmacokinetic study in humans.
