Development and validation of simple and rapid LC-MS/MS method for ezetimibe in human plasma and its application to bioequivalence study
Journal Title: IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) - Year 2017, Vol 17, Issue 2
Abstract
A sensitive and specific liquid chromatography combined with electrospray ionization (ESI) tandem mass spectrometry (LC-MS/MS) method, operating in the negativeionization mode, for quantifying of ezetimibe in human plasma using ezetimibe-d4 as internal standard (IS) was developed and validated. The analyte and IS were extracted by simple one step liquid to liquid extraction (LLE). The chromatographic separation was performed on a Gemini C18 column (50 X 2.0 mm, 5 um) under isocratic conditions using a mixture of acetonitrile/0.1% formic acid (70:30, v/v) as mobile phase at a flow rate of 0.20 ml/min. Quantitation was performed using multiple reaction monitoring (MRM) mode to study parent → product ion transitions of m/z 408.0→270.8 for ezetimibe and m/z412.1→270.8 for IS, respectively. Linearity in plasma was obtained over the concentration range 0.1 ~ 20 ng/ml, with a coefficient of determination (r2 ) of 0.9999. The method was has been successfully applied for routine assay to support pharmacokinetic study of ezetimibe in human plasma after an oral administration of 10 mg ezetimibe.
Authors and Affiliations
Yong Sun Park, Dong Pil Kimb, Suk Hong Kang, Ki Tak Kimb ,, Yong Hwan Kim, Jong Hoon Kim, Ye Na Kim, Jin Young Kima, Soo Ji Sim, Bo Ra Jin, Heon Soo Leea
Keywords
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- EP ID EP390311
- DOI 10.9790/3008-1204070108
- Views 100
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