A simple and sensitive LC-MS/MS method was successfully developed and applied for the quantification of ambrisentan in human plasma during a pharmacokinetic study.
Enables reliable ambrisentan quantification for PK studies; leaves open routine clinical adoption pending further validation.
A simple and sensitive liquid chromatography tandem mass spectrometry method has been developed for the quantification of ambrisentan (AMB) in human plasma using midazolam (MID) as an internal standard (IS). Chromatographic separation was performed using a Beta Basic-8 (50 × 4.6 mm, 5 µm) column with an isocratic mobile phase. AMB and MID were detected with proton adducts at m/z 379.09 → 303.12 and 326.15 → 291.14 in multiple reaction monitoring-positive mode, respectively. A solid-phase extraction method was used for extraction of the analyte and IS from the plasma samples. The method was shown to be reproducible and reliable with within-run precision <11%, between-run precision <14% and linear concentration range from 10.0 to 2000.2 ng/mL, with a correlation coefficient (r(2) ) of >0.995. The method was successfully applied to a pharmacokinetic study of oral administration of AMB (10 mg) in 24 healthy Indian male human volunteers under fasting conditions.
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Lukram et al. (2014) studied this question.
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