Development and validation of analytical method for the determination of radotinib in human plasma using liquid chromatography-tandem mass spectrometry.
10.12793/tcp.2017.25.4.183
- Author:
Hyo Bum SEO
1
;
Seungil CHO
;
Young Ran YOON
;
Dong Seok YIM
Author Information
1. Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea. yimds@catholic.ac.kr
- Publication Type:Original Article
- Keywords:
Radotinib (IY5511);
HPLC-MS/MS;
Human plasma;
Method validation;
Pharmacokinetic study
- MeSH:
Amlodipine;
Calibration;
Chromatography, Liquid;
Ether;
Humans*;
Liquid-Liquid Extraction;
Mass Spectrometry*;
Methods*;
Plasma*;
Quality Control;
Tandem Mass Spectrometry
- From:Translational and Clinical Pharmacology
2017;25(4):183-189
- CountryRepublic of Korea
- Language:English
-
Abstract:
This study describes the development of an analytical method to determine radotinib levels in human plasma using high performance liquid chromatography (HPLC) coupled with triple quadrupole tandem mass spectrometry (MS/MS) for pharmacokinetic application. Plasma samples were sequentially processed by liquid-liquid extraction using methyl tert-butyl ether, evaporation, and reconstitution. Analytes were separated and analyzed using HPLC-MS/MS in selected reaction monitoring mode, monitoring the specific transitions of m/z 531 to 290 for radotinib and m/z 409 to 238 for amlodipine (internal standard). The HPLC-MS/MS analytical method was validated with respect to selectivity, linearity, sensitivity, accuracy, precision, recovery, and stability. Calibration curves were linear over a concentration range 5–3,000 ng/mL with correlation coefficients (r) > 0.998. The lower limit of quantification for radotinib in plasma was 5 ng/mL. The accuracy and precision of the analytical method were acceptable within 15% at all quality control levels. This method was suitable to determine radotinib levels in human plasma because of its simplicity, selectivity, precision, and accuracy.
