ID 106039
Author
Shibata, Masaaki Department of Pharmacy, National Hospital Organization Nagoya Medical Center
Takahashi, Masaaki Department of Pharmacy, National Hospital Organization Nagoya Medical Center
Yoshino, Munehiro Department of Pharmacy, National Hospital Organization Osaka Medical Center
Kuwahara, Takeshi Department of Pharmacy, National Cerebral and Cardiovascular Center Hospital
Nomura, Toshiharu Department of Pharmacy, National Hospital Organization Nagoya Medical Center
Yokomaku, Yoshiyuki Department of Clinical Research Center, National Hospital Organization Nagoya Medical Center
Sugiura, Wataru Department of Clinical Research Center, National Hospital Organization Nagoya Medical Center
Keywords
rilpivirine
LC-MS
HIV
therapeutic drug monitoring
Content Type
Journal Article
Description
Rilpivirine (TMC-278) is a second-generation non-nucleoside reverse transcriptase inhibitor that is high potent against both wild-type and drug-resistant HIV-1 strains. Therefore, rilpivirine is expected to treat therapy-experienced patients who failed to use current drugs due to the emergence of drug-resistant HIV mutants. The quantification of rilpivirine in human plasma is important to support clinical studies and determine pharmacokinetic parameters of rilpivirine in HIV-1 infected patients. Consequently, simple and easy system to determine plasma rilpivirine concentrations has been required. In this study, we developed a conventional LC-MS method to quantify plasma rilpivirine. Subsequently the method was validated by estimating the precision and accuracy for inter- and intraday analysis in the concentration range of 18-715 ng/ml. The calibration curve was linear in this range. Average accuracy ranged from 100.0 to 100.6%. Relative standard deviations of both inter- and intraday assays were less than 3.3%. Recovery of rilpivirine was more than 82.0%. These results demonstrate that our LC-MS method provides a conventional, accurate and precise way to determine rilpivirine in human plasma. This method can be used in routine clinical application for HIV-1 infected patients, and permits management of drug interactions and toxicity for rilpivirine.
Journal Title
The journal of medical investigation : JMI
ISSN
13431420
NCID
AA11166929
Volume
60
Issue
1-2
Start Page
35
End Page
40
Sort Key
35
Published Date
2013-02
FullText File
language
eng
TextVersion
Publisher