Abstract
DEVELOPMENT AND VALIDATION OF A HIGHLY SENSITIVE LC-MS/MS METHOD FOR DETERMINATION OF DAPOXETINE IN HUMAN PLASMA: APPLICATION TO A BIOEQUIVALENCE STUDY.

Hamed Hamed Abu Seada, Khalid Abdel-Salam Attia, Mohammad Wafaa Nassar, Ahmed El Hamouly*

ABSTRACT

In this study, an attempt was made to describe and validate a liquid chromatography coupled with tandem mass spectrometry method for the quantification of dapoxetine; a selective serotonin re-uptake inhibitor in human EDTA Na2 plasma according to the current bioanalytical guidelines. The internal standard used was reboxetine. The separation was performed on a Luna C18 5μm, 100A (50 x 4.6 mm), (Phenomenex) column under isocratic conditions using a mobile phase of acetonitrile and 0.5% formic acid in water 80:20 (v/v) at ambient temperature with a flow rate of 1.0 ml/min. The detection of dapoxetine and the internal standard was performed in multiple reaction monitoring (MRM) mode using a Triple quadrupole LC/MS/MS Mass Spectrometer with electro spray ionization, operating in positive ion mode. The human plasma samples (0.25 ml) were extracted using liquid-liquid extraction with tertiary butyl methyl ether. The method shows a good linearity (R2 > 0.996), precision (CV< 8.8%) and accuracy (bias < 8.5%) over the range of 0.1-1200 ng/ml dapoxetine in plasma. The recovery was between 82.03 and 84.6%. The limit of quantification was 0.1 ng/ml. The analysis required only a 1.2 minutes run. The developed and validated method for the determination of dapoxetine in human plasma was successfully applied in a bioequivalence study, for analysing approximately 800 subject’s samples.

Keywords: Dapoxetine, bioequivalence study, LC-MS/MS, method validation, plasma extraction, premature ejaculation.


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