Abstract
A simple, rapid and robust high-throughput assay for the quantitative analysis of irbesartan in plasma from two species using liquid chromatography tandem mass spectrometric method was developed and validated. Solid phase extraction was used and quantification was achieved using a positive electrospray ionization interface under multiple reactions monitoring condition. Complete validation (as per recent regulatory requirements) was done using human plasma. The same method was validated using dog plasma and the validation parameters met respective acceptance criteria. The method has shorter run time of 3 min. This will help in high throughput. The low aliquot volume in the method helped us to take enough sampling time points for better pharmacokinetic profiles. The calibration curve was shown to be linear from 12.1 to 6018.7 ng/ml in human plasma and 12.1 to 5987.2 ng/ml in dog plasma. This method was successfully applied to samples collected during bioavailability studies of irbesartan in humans and dogs.
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