A sensitive HPLC–MS–MS method for the determination of raltegravir in human plasma

This work describes an assay system that has been developed to quantify raltegravir concentrations in human plasma using a liquid–liquid extraction technique paired with HPLC separation and MS–MS detection. The dynamic range of this assay extends from 1 to 3000 ng/mL, with a coefficient of determination (r2, mean ± SD) of 0.9992 ± 0.0002. The mean precision values for calibration standards ranged from 0.6% to 3.0%, while accuracy values were 96.5–104.3%. This procedure is an accurate, precise, and sensitive method for raltegravir quantitation and was successfully validated using external proficiency testing.