A simple, highly sensitive ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for the determination of Doxorubicin using Ketotifen as internal standard in human plasma. After a simple protein precipitation using methanol, Doxorubicin and Ketotifen (I.S) were separated using Acquity<sup>®</sup> UPLC BEH™ C<sub>18</sub> (50 × 2.1 mm, i.d. 1.7 μm, Waters, USA) reversed phase column, and a mixture of acetonitrile-water- formic acid (70:30:0.1% v/v/v) as mobile phase, delivered at 200 µl/min. Doxorubicin and I.S were eluted at 0.49 minutes. The mass spectrometric determination was carried out using an electrospray interface operated in the positive mode with multiple reactions monitoring (MRM) mode. The precursor to product ion transitions of m/z 544.25 &gt; 397.16 and m/z 310.08 &gt; 95.97 were used to quantify Doxorubicin and Ketotifen, respectively. The method was linear in the concentration range of 10–1000 ng/mL with a limit of quantitation of 10 ng/mL. The method was validated according to the United States Food and Drug Administration (US-FDA) and European Medicines Agency (EMEA) guidelines. All the validation parameters were in the ranges acceptable by the guidelines of bionalytical method validation.

Development and validation of a sensitive ultra-performance liquid chromatographic method with tandem mass spectrometry for quantification of doxorubicin in human plasma

253rd National Meeting (2017)

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