Novel and rapid LC–MS/MS method for quantitative analysis of methylphenidate in dried blood spots-Reference-Cited by-同舟云学术

Novel and rapid LC–MS/MS method for quantitative analysis of methylphenidate in dried blood spots

Published:2018-06-01 Issue:11 Volume:10 Page:839-850
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Gandhi Adarsh¹,Beekman Christopher²,Parker Robert¹,Fang Lanyan³,Babiskin Andrew³,Matta Murali K¹

Affiliation:

1. Office of Clinical Pharmacology, Center for Drugs Evaluation & Research, US Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

2. Office of Pharmaceutical Quality, Center for Drugs Evaluation & Research, US Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

3. Office of Generic Drugs, Office of Clinical Pharmacology, Center for Drugs Evaluation & Research, US Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

Abstract

Aim: Development and validation of a novel, sensitive, specific and rapid dried blood spots (DBS)-LC–MS/MS method for methylphenidate (MPH), an attention-deficit hyperactivity disorder drug. Methodology & results: Protein precipitation with acetonitrile was used to extract MPH from the DBS cards. Chromatographic separation was achieved on a Zorbax C18 column using an isocratic mobile phase composed of acetonitrile and 5 mM ammonium formate buffer (20:80, v/v) at a flow rate of 0.5 ml/min. MPH was quantified over a linear range of 200–25,000 pg/ml. Conclusion: The clinical DBS-LC–MS/MS method was successfully validated as per the US FDA's Bioanalytical Method Validation Guidance to support an ongoing pediatric pharmacokinetic study.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio-2018-0024

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