NDLI: Accuracy Profile Theory for the Validation of an LC–MS-MS Method for the Determination of Risperidone and 9-Hydroxyrisperidone in Human Plasma

Content Provider	Springer Nature Link
Author	Zhang, Xianhua Zhao, Xia Zhang, Chao Yang, Li Xiong, Xin Zhou, Yong Yang, Yiheng Duan, Jingli
Copyright Year	2010
Abstract	A sensitive and specific LC–MS-MS method is described for the simultaneous quantification of risperidone and 9-hydroxyrisperidone in human plasma. After extraction with tert-butyl methyl ether, plasma samples were separated on an Atlantis HILIC Silica C18 column (4.6 × 150 mm, 5 μm)with a mobile phase of ammonium formate buffer (10 mM, pH 4.0)/acetonitrile (40/60, v/v). Detection was by MS-MS. The method was fully validated according to the accuracy profile theory. It is based on β-expectation tolerance interval for the total measurement error which includes trueness and intermediate precision. The measurement uncertainty derived from β-expectation tolerance interval was estimated at each of the validation standards. The linearity fitted well over the range of 0.11–26.75 ng mL−1 for risperidone with an LLOQ of 0.11 ng mL−1, and for 9-hydroxyrisperidone, at a range of 0.15–37.8 ng mL−1 with an LLOQ of 0.15 ng mL−1. The intra- and inter-batch precision of risperidone were <5.71 and 8.22%, respectively. For 9-hydroxyrisperidone, the data were 5.78 and 6.48%. The recoveries were 88.78% (risperidone) and 70.35% (9-hydroxyrisperidone). The developed method was applied to a pharmacokinetic study of risperidone.
Starting Page	1015
Ending Page	1023
Page Count	9
File Format	PDF
ISSN	00095893
Journal	Chromatographia
Volume Number	71
Issue Number	11-12
e-ISSN	16121112
Language	English
Publisher	Vieweg Verlag
Publisher Date	2010-04-24
Publisher Place	Wiesbaden
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Column liquid chromatography Tandem mass spectrometry Measurement uncertainty Risperidone and 9-hydroxyrisperidone Measurement Science and Instrumentation Plant Sciences Biochemistry Pharmacy Organic Chemistry Analytical Chemistry
Content Type	Text
Resource Type	Article
Subject	Organic Chemistry Analytical Chemistry Biochemistry Clinical Biochemistry

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