Development and Validation of Liquid Chromatography/Tandem Mass Spectrometry Analysis for Therapeutic Drug Monitoring of Risperidone and 9-Hydroxyrisperidone in Pediatric Patients with Autism Spectrum Disorders.

Abstract:

BACKGROUND:Risperidone (RIS) is a widely used atypical antipsychotic drug. We developed and validated a sensitive and accurate LC-MS/MS method, which requires a small-volume of plasma and small-volume injection for measurement of RIS levels in ASD pediatric patients. We also investigated the relationship between RIS levels and RIS dosages, including prolactin levels. METHOD:Blood samples were processed by protein precipitation extraction. Only 1 μl of sample was injected. Plasma samples were separated on a C18 column (4.6 cm × 50 mm; 1.8 μm particle size). Detection was by MS-MS with an analytical run time of 6 min. RESULTS:The inter-day accuracy of RIS was 101.33-107.68% and 95.24-103.67% for 9-OH-RIS. The inter-day precision of RIS was ≤7.27% CV and ≤7.41% CV for 9-OH-RIS. The extraction recovery of RIS and 9-OH-RIS were 95.01 ± 7.31-112.62 ± 7.50% and 90.27 ± 11.15-114.00 ± 10.35%, respectively. This method was applied in the therapeutic drug monitoring of ASD pediatric patients. Higher RIS dosage has a tendency to produce higher RIS plasma levels. The high RIS plasma levels have a tendency to produce hyperprolactinemia. CONCLUSION:The determination of RIS in individual patients might be clinically useful for monitoring and prediction of treatment response.

journal_name

J Clin Lab Anal

authors

Vanwong N,Prommas S,Puangpetch A,Hongkaew Y,Nuntamool N,Nakorn CN,Ngamsamut N,Limsila P,Sukasem C

doi

10.1002/jcla.22009

subject

Has Abstract

pub_date

2016-11-01 00:00:00

pages

1236-1246

issue

6

eissn

0887-8013

issn

1098-2825

journal_volume

30

pub_type

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