Determination of Lisdexamfetamine in Human Plasma by LC-MS/MS Method

Lisdexamfetamine is a prodrug that is converted to d-amphetamine in the body, mainly used to treat attention deficit hyperactivity disorder in children and adults. Its mechanism involves the enhancement of neurotransmitters such as norepinephrine and dopamine, which are critical for attention and behavioral regulation. With the upcoming patent expiration of Vyvanse^®, bioanalytical methods for the quantification of lisdexamfetamine in plasma are needed for use in pharmacokinetic studies. In this work, we developed and validated a sensitive bioanalytical method using liquid chromatography-tandem mass spectrometry (LC-MS/MS) for lisdexamfetamine quantification in human plasma. The method developed was performed for 4 min per sample and using the concentration range of 0.3-100 ng mL^-1. Intra-batch, inter-batch and instrument reproducibility, the precision was lower than 10%. The results demonstrated that the method is rapid, sensitive, robust, and suitable for pharmacokinetic studies.

Keywords:
bioanalytical method; LC-MS/MS; lisdexamfetamine; pharmacokinetics