title: Method validation and determination of lisdexamfetamine and amphetamine in oral fluid, plasma and urine by LC-MS/MS.
abstract: Lisdexamfetamine (LDX) is a long-acting prodrug stimulant indicated for the treatment of attention-deficit/hyperactivity disorder and binge-eating disorder symptoms. In vivo hydrolysis of LDX amide bond releases the therapeutically active d-amphetamine (d-AMPH). Since toxicological tests in biological samples can detect AMPH from the use of some legal medications, efficient methods are needed in order to correctly interpret the results. The aim of this study was to develop and validate an LC-MS/MS method for the simultaneous quantification of LDX and its main biotransformation product AMPH in human oral fluid, plasma and urine. Calibration curve range for both analytes was 1-128 ng/mL in oral fluid and plasma and 4-256 ng/mL in urine, being the lowest concentration the limit of quantification. Accuracy of the determined values of the target analytes for the five control levels ranged from 94.8 to 111.7% for oral fluid, from 91.3 to 100.2% for plasma and from 94.8 to 109.8% for urine. Imprecision for the five control levels did not exceeded 12.8% for oral fluid, 16.2% for plasma and 17.1% for urine. The method developed for the three matrices was validated and was also successfully applied to assess real samples, showing for the first time the detection of LDX in oral fluid.
authors: Graduate Studies Program in Pharmaceutical Sciences, Faculty of Pharmacy, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.
authors: Eloisa
authors: E
authors: Comiran
authors: National Agricultural Laboratory - LANAGRO/RS, Ministry of Agriculture, Livestock and Food Supply, Porto Alegre, Rio Grande do Sul, Brazil.
authors: Fabiano
authors: F
authors: Barreto
authors: Graduate Studies Program in Pharmaceutical Sciences, Faculty of Pharmacy, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.
authors: Leonardo Z
authors: LZ
authors: Meneghini
authors: Graduate Studies Program in Pharmaceutical Sciences, Faculty of Pharmacy, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.
authors: Graciela
authors: G
authors: Carlos
authors: Graduate Studies Program in Pharmaceutical Sciences, Faculty of Pharmacy, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.
authors: Pedro E
authors: PE
authors: Fröehlich
authors: Graduate Studies Program in Pharmaceutical Sciences, Faculty of Pharmacy, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.
authors: Renata Pereira
authors: RP
authors: Limberger
mesh_terms: D000661:Amphetamine / Q000032:analysis* / Q000097:blood / Q000652:urine; D002853:Chromatography, Liquid; D019963:Clinical Chemistry Tests / Q000379:methods* / Q000592:standards; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate / Q000032:analysis* / Q000097:blood / Q000652:urine; D015203:Reproducibility of Results; D012463:Saliva / Q000737:chemistry; D053719:Tandem Mass Spectrometry
chemical_list: D000661:Amphetamine; D000069478:Lisdexamfetamine Dimesylate
keywords: amphetamine; bioanalysis; liquid chromatography-mass spectrometry; lisdexamfetamine; toxicology