Abstract

VALIDATED UPLC/Q-TOF-MS METHOD FOR SIMULTANEOUS DETERMINATION OF DICLOFENAC AND PARACETAMOL IN HUMAN PLASMA AND ITS APPLICATION TO PHARMACOKINETIC STUDY

Hamid Khan*

ABSTRACT

An ultra-performance liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC/Q-TOF-MS) method has been developed and validated for simultaneous determination of diclofenac sodium and paracetamol in human plasma. Both the drugs were analyzed by Acquity UPLC BEH C18 (100.0 × 2.1 mm, 1.7 μm) column using isocratic mobile phase consisting of acetonitrile-2mM ammonium acetate (50:50, v/v) at a flow rate of 0.20 mL/min. The Q-TOF mass spectrometer was operated in positive ionization mode and quantitation was done using the MS/MS transitions m/z 296.95 to 215.05 for diclofenac sodium, and 152.07 to 110.06 for paracetamol. The calibration curves were linear over the concentration range of 1-1000 ng/mL for both the drugs. The developed method was validated according to ICH guidelines. The method was applied for pharmacokinetic study of FDC tablets containing diclofenac sodium and paracetamol in human plasma.

Keywords: UPLC/Q-TOF-MS, Diclofenac Sodium, Paracetamol, Pharmacokinetic Study.