Selective and rapid determination of raltegravir in human plasma by liquid chromatography-tandem mass spectrometry in the negative ionization mode
10.1016/j.jpha.2014.10.002
- Author:
Gupta Ajay
;
Guttikar Swati
;
Shah A. Priyanka
;
Solanki Gajendra
;
Shrivastav S. Pranav
;
Sanyal Mallika
- Publication Type:Journal Article
- Keywords:
Raltegravir;
LC-ESI-MS/MS;
Negative ionization mode;
Human plasma;
Bioequivalence study
- From:
Journal of Pharmaceutical Analysis
2015;(2):101-109
- CountryChina
- Language:Chinese
-
Abstract:
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.
