Determination of Dapoxetine Hydrochloride in Human Plasma by HPLC-MS/MS and Its Application in a Bioequivalence Study.

ABSTRACT: Dapoxetine is used for the treatment of premature ejaculation. The present study developed an HPLC-MS/MS method to determine the levels of dapoxetine in human plasma processed using simple protein precipitation. Dapoxetine-d₇ was selected as the internal standard. The established method was performed using a mass spectrometer equipped with an electrospray ionization source in multiple positive ion reactions to monitor the mode using the precursor-to-product ion transitions of m/z 306.2-157.2 and m/z 313.2-164.2 for dapoxetine-d7 and dapoxetine, respectively. The method was evaluated based on its selectivity, linearity, limit of quantification, precision, accuracy, matrix effects, dilution integrity, stability, and extraction recovery. As a result of the model used

SUBMITTER: Zhang X 

PROVIDER: S-EPMC9101379 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature