Sensitive and specific liquid chromatography-tandem mass spectrometric method for the quantitation of dexmedetomidine in pediatric plasma.

Dexmedetomidine (Dex) is a lipophilic imidazole derivative used primarily for the sedation and anxiolysis of adults in the intensive care setting. Dex is being used more frequently in the pediatric intensive care unit. This report describes a selective and highly sensitive assay for Dex in pediatric plasma employing liquid chromatography-tandem mass spectrometry (LC-MS/MS). Dex was extracted from 200 microL of plasma by solid-phase extraction (SPE). High performance liquid chromatography (HPLC) separation was conducted on an YMC ODS-AQ C(18) column with a flow rate of 0.3 mL/min using a mobile phase comprised of 5 mM ammonium acetate buffer/0.03% formic acid in the solvent mixture of methanol/acetonitrile/water (20:20:60, v/v/v). The intra-day precision (coefficient of variation, % CV) and accuracy for quality control samples, ranged from 1.04 to 6.84% and 90.2 to 100.8%, respectively. The inter-day precision and accuracy ranged from 4.08 to 5.37% and 92.7 to 98.6%, respectively. Stability studies showed that Dex was stable during both the assay procedure and storage. The overall recovery was 76.6-78.3% for Dex in plasma. The analytical method showed excellent sensitivity using a small sample volume (200 microL) with a lower limit of quantitation of 5 pg/mL. This method is robust and has been successfully employed in a pharmacokinetic study of Dex in infants postoperative from cardiac surgery.