Volume 5 Issue 2
Apr.  2015
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Ajay Gupta, Swati Guttikar, Priyanka A. Shah, Gajendra Solanki, Pranav S. Shrivastav, Mallika Sanyal. Selective and rapid determination of raltegravir in human plasma by liquid chromatography-tandem mass spectrometry in the negative ionization mode[J]. Journal of Pharmaceutical Analysis, 2015, (2): 101-109. doi: 10.1016/j.jpha.2014.10.002
Citation: Ajay Gupta, Swati Guttikar, Priyanka A. Shah, Gajendra Solanki, Pranav S. Shrivastav, Mallika Sanyal. Selective and rapid determination of raltegravir in human plasma by liquid chromatography-tandem mass spectrometry in the negative ionization mode[J]. Journal of Pharmaceutical Analysis, 2015, (2): 101-109. doi: 10.1016/j.jpha.2014.10.002

Selective and rapid determination of raltegravir in human plasma by liquid chromatography-tandem mass spectrometry in the negative ionization mode

doi: 10.1016/j.jpha.2014.10.002
Funds:

Veeda Clinical Research, Ahmedabad, India

  • Publish Date: Apr. 10, 2015
  • A selective and rapid high-performance liquid chromatography–tandem mass spectrometry method was developed and validated for the quantification of raltegravir using raltegravir-d3 as an internal standard (IS). The analyte and IS were extracted with methylene chloride and n-hexane solvent mixture from 100 mL human plasma. The chromatographic separation was achieved on a Chromolith RP-18e endcapped C18 (100 mm ? 4.6 mm) column in a run time of 2.0 min. Quantitation was performed in the negative ionization mode using the transitions of m/z 443.1-316.1 for raltegravir and m/z 446.1-319.0 for IS. The linearity of the method was established in the concentration range of 2.0–6000 ng/mL. The mean extraction recovery for raltegravir and IS was 92.6% and 91.8%, respectively, and the IS-normalized matrix factors for raltegravir ranged from 0.992 to 0.999. The application of this method was demonstrated by a bioequivalence study on 18 healthy subjects.
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