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.

• Authors: Natchaya Vanwong, Santirat Prommas, Apichaya Puangpetch, Yaowaluck Hongkaew, Nopadol Nuntamool, Chalitpol Na Nakorn, Nattawat Ngamsamut, Penkhae Limsila, Chonlaphat Sukasem
• Journal: Journal of clinical laboratory analysis (J Clin Lab Anal) Vol. 30 Issue 6 Pg. 1236-1246 (Nov 2016) ISSN: 1098-2825 [Electronic] United States
• PMID: 27346210 (Publication Type: Journal Article, Validation Study)
• Copyright: © 2016 Wiley Periodicals, Inc.

Chemical References

• Antipsychotic Agents
• Risperidone
• Paliperidone Palmitate

Topics

• Antipsychotic Agents (blood, therapeutic use)
• Autism Spectrum Disorder (blood, drug therapy)
• Chromatography, Liquid
• Drug Monitoring (methods)
• Female
• Humans
• Male
• Paliperidone Palmitate (blood, therapeutic use)
• Risperidone (blood, therapeutic use)
• Statistics as Topic
• Statistics, Nonparametric
• Tandem Mass Spectrometry