ISSN: 2249–9504
CAS CODEN: IJPCDX

DEVELOPMENT AND VALIDATION OF BIOANALYTICAL METHOD FOR MACITENTAN IN HUMAN PLASMA USING LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY

Abstract

Author(s): Chirag D Patel1,2, Swati Guttikar1 and Bhavesh H Patel2*

The present study describes a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the macitentan in human plasma using liquid liquid extraction technique. Method of macitentan has been developed and validated using macitentan D4 as internal standard. Electro spray ionization technique was used in this method. Analytes were recovered by liquid liquid extraction method and subsequently separated C18l column using 0.5% Formic Acid in water :Acetonitrile, 20:80v/v as a mobile phase, at a flow rate of 1.0 mL/min. Quantification of macitentan and macitentan D4 was performed using multi-reaction monitoring mode (MRM) in positive mode. The calibration curve was linear (r 2 > 0.99) over the concentration range of 1.00 to 500 ng/mL for macitentan. The intra-day and inter-day precisions were less than 15% and the accuracy was all within ±15% (at LLOQ level ±20%). The LC-MS/MS method was fully validated for all the other parameters such as selectivity, matrix effect, recovery and stability as well. In conclusion, the findings of the present study revealed the selectivity and sensitivity of this method for the macitentan in human plasma.

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